Report of the Ministerial Inquiry into the Under-reporting
of Cervical Smear Abnormalities in the Gisborne Region
5. Term of Reference Two
What are the factors that are likely to have led to the
under-reporting?
5.1 Dr Bottrill was at a loss to explain why so many
of the cervical smear tests read at Gisborne Laboratories had been under-reported.
The only explanation he could offer was that his work performance had
deteriorated after he had undergone heart surgery in July 1990.
5.2 Counsel for the women affected submitted that in
answering Term of Reference Two the Committee should identify both direct
and indirect factors that are likely to have led to under-reporting.
However, Counsel for the Ministry of Health submitted that even if there
were defects in the Programme’s delivery, those defects could not have
led to the under-reporting. The Committee considers that the phrase
" to identify the factors that are likely to have led to that under-reporting"
has a meaning which goes beyond identifying the immediate cause of the
under-reporting. Clearly the immediate cause of any under-reporting
is someone misreading a smear test. By directing the Committee to identify
the factors that are likely to have led to unacceptable under-reporting
the Minister of Health is seeking an answer which may go some way to
explain how the under-reporting came about. This will inform the Minister
of the steps that need to be taken to ensure that unacceptable under-reporting
is avoided in the future. Unless the Minister is made aware of all the
factors without which damage could not have occurred the Minister will
not be best placed to determine the remedial action required. For this
reason the Committee considers that Term of Reference two requires it
to look for all factors which directly or indirectly materially contributed
to the under-reporting.
5.3 In the Committee’s view there are a number of factors
that are likely to have led to the unacceptable level of under-reporting
at Gisborne Laboratories. These factors fall into two groups: those
that relate directly to the practices followed in Gisborne Laboratories
when reading cervical cytology; and those that relate to the delivery
of cytological services in New Zealand between the years 1990 to 1996.
The second group of factors directly influenced how cervical cytology
was carried out in Gisborne Laboratories during this time. Each group
of factors is discussed in turn below.
Factors Relating To Practices Followed In Gisborne
Laboratories
5.4 The factors relating to practices in Gisborne Laboratories
that are likely to have led to under-reporting of cervical smear tests
are:
(i) No specialised division of labour for reading
cervical smear tests;
(ii) Inadequate internal quality control including
no organised correlation of biopsy results with cytology results;
(iii) Inadequate systems and procedures;
(iv) No external quality control;
(v) No accreditation with an independent quality
control authority;
(vi) Dr Bottrill’s inadequate participation in continuing
medical education; and
(vii) No awareness that the laboratory’s practices
put patients at risk.
Each of these factors, their impact on the laboratory’s
performance and the likelihood of them leading to under-reporting is
discussed below.
No Specialised Division Of Labour For Reading Cervical
Smear Tests
5.5 In most laboratories cervical smear tests are screened
by more than one person. The usual practice is for a specially trained
cytotechnologist or cytoscreener to carry out the primary screening.
This entails the careful microscopic examination of slides on which
cellular material from the cervical smear is fixed. It can be a monotonous
repetitive task as the examination of each slide follows a set pattern.
Cytotechnologists and cytoscreeners are trained to look for unusual-looking
cells on the slide as these indicate cellular abnormalities. Their task
is to sort the abnormal from the normal smears. Once the abnormal smears
are identified they are sent to the laboratory pathologist who also
examines them and then categorises the type of cellular abnormality.
5.6 The importance of a specialised division of labour
when reading cervical cytology has been well recognised for some time.
The World Health Organisation issued a Bulletin in 1986 titled Control
of Cancer of the Cervuix Uteri which stated:
"All smears should be processed
and screened at a cytology laboratory in which the following procedures
must be performed: staining, examination by a cytotechnologist,
confirmation by a cytopathologist, communication of results to a clinician
and follow-up of all cases of abnormal cytology. (emphasis added)
In the same passage the need for pathologists and other
laboratory staff to maintain their competency in cervical cytology by
reading a large volume of cervical smear tests and by avoiding working
in isolation was also recognised:
"Cytology services should be
centralised. A large volume of work contributes to the successful
operation of a cytology laboratory because a specialized division
of labour is possible and a large number of abnormal smears representing
various pathologies will help to maintain the cytotechnologists’ skills.
…Usually single unsupervised technicians should not be placed in isolated
areas or health centres, since even well trained screeners will lose
their skills if not exposed to a large number of positive specimens,
teaching and supervision."
5.7 At Gisborne Laboratories there was no specialised
division of labour when it came to reading cervical smear tests. The
cervical cytology was read by one person, and this was usually Dr Bottrill.
He was the only pathologist that Gisborne Laboratories permanently employed.
Of the 22,976 smear tests sent to Douglass Hanly Moir Pathology in Sydney
for re-reading, 20,860 had originally been read by Dr Bottrill. Gisborne
Laboratories received approximately 4000-5000 cervical smear tests per
annum.
5.8 Dr Bottrill carried out all the primary screening
of the smear tests, even though he had no specialist training in cytoscreening.
On the occasions when Dr Bottrill went on leave and a locum was employed
the locum also carried out the entire task. On his return from leave
Dr Bottrill did not check the smear tests which the locum had read.
Occasionally, when the workload became too heavy, Dr Bottrill employed
a locum to assist him. Once again the practice was for Dr Bottrill and
the locum to work separately on an allotted group of slides. Dr Bottrill
said that for the first week he would check the locum’s work by re-reading
the smear tests and the reports; after that the locum was left to do
his allotted work. Dr Bottrill used to rescreen 10% of the negative
smear tests approximately once a week and when a locum was employed
it seems that Dr Bottrill included the smear tests the locum read in
the rescreening exercise. This was the limit of any sharing of the task
of reading cervical smear tests.
5.9 The Committee heard no evidence to support primary
screening of cervical smear tests being performed by a pathologist.
Professor McGoogan, Dr Gabriel Medley and Dr Farnsworth are highly qualified
and experienced cytopathologists. They each informed the Committee that
they considered their skills were not suited to primary screening. In
her evidence to the Committee Professor McGoogan said:
Dr Duggan Question Could I ask you
for your own personal opinion on whether pathologists who have not
been trained in the skills of primary screening should function
as a primary screener?
A I have a very high regard for
the skills of primary screeners, it is an exceptionally difficult
skill to develop and maintain day in day out. It is not a skill
which I have as an individual. I would have to undertake a similar
training and concentrate my training in that area to achieve the
same skills.
Q You, as an acknowledged expert
in cytopathology, do not consider you should function as a primary
screener .....
A Yes, I agree.
5.10 Other pathologists from whom the Committee heard
evidence also did not think it advisable for a pathologist to perform
primary screening. Dr Beer, a pathologist from Tauranga who gave evidence
for the Association of Community Laboratories said he thought it dangerous
for a pathologist to perform primary screening. Dr Teague, who gave
evidence for the Royal College of Pathologists of Australasia said he
did not consider himself competent to primary screen cervical smear
tests and that he would not function as a primary screener. Dr Teague
had organised a review of a small group of Dr Bottrill’s slides for
an accident compensation claim against Dr Bottrill for medical misadventure
due to the under-reporting of a patient’s cervical smear test. When
Dr Teague learnt how Dr Bottrill practised cervical cytology he advised
Dr Bottrill to stop reading smear tests and to send the laboratory’s
cervical cytology elsewhere; Dr Bottrill did not follow Dr Teague’s
advice.
5.11 Dr Bottrill said that he had not wanted to act
as his own primary screener and that he had done so because: between
the years 1990 and 1995 there was a shortage of cytotechnologists; Gisborne
Laboratories did not have enough work to employ a full time screener;
and given the shortage of cytotechnologists it was too difficult to
find someone prepared to do this work part time in a rural area like
Gisborne. An additional reason Dr Bottrill gave for carrying out the
primary screening was that he wished to offer a full service to the
Gisborne region and the alternative to him carrying out the primary
screening was for Gisborne Laboratories to send cervical cytology elsewhere.
5.12 None of the reasons Dr Bottrill gave for the laboratory
following this practice justifies it. There was no question of Dr Bottrill
acting out of necessity. The cervical cytology of women from the Gisborne
region could have been read at a laboratory in another region. All the
cervical cytology from the Gisborne region is now read by laboratories
in other regions. Since Medlab Hamilton purchased Gisborne Laboratories
the cervical cytology that was read by Gisborne Laboratories is read
in Hamilton. The Gisborne hospital laboratory has ceased reading cytology
and sends any cytology it receives elsewhere. When Dr Bottrill was in
practice, but on sick leave the cervical cytology Gisborne Laboratories
received was read in a laboratory in Palmerston North. Between 1990
to 1996 there was no obstacle which prevented Gisborne Laboratories
from sending cervical cytology elsewhere, if it had chosen to do so.
5.13 The practice of working alone that Dr Bottrill
followed meant there was no opportunity for a second pair of eyes to
view the cervical smear tests that he screened. Consequently, unless
he arranged to seek a second opinion on a smear test, there was no likelihood
of any error he made in reading a smear test being picked up. The Committee
heard evidence from more than one pathologist on the risk of this practice
to patients. The best evidence was given by Professor McGoogan:
CHAIR: Question I will start the
scenario again, a small laboratory where you have one pathologist,
no-one else employed full or part time, approximately 5000 smears
per annum coming into the laboratory, the single pathologist doing
all screening primary and then I don't know the format he used to
screen abnormals, but have you got enough in front of you now to
formulate an opinion? .....
A Yes. this is in my experience
a very unusual situation. It is difficult in a situation where there
is only one person for that individual to quality control themselves
and while it is not impossible to maintain quality service under
those circumstances it would be extremely difficult and would require
exceptional measures to be put in place by the individual to ensure
competence and a quality service.
Q Can you describe how it might
be done, in other words, what those quality control measures might
be?
A I can think of ways but what you
are really asking me is if I want to set up a bad service how would
I do it with the least risk to women.
Q You have said it could be done,
so please outline the measures? .....
A There would have to be frequent
and good interaction with pathologists in another laboratory whereby
there was exchange of work between the two laboratories or at least
in one direction from the single handed pathologist laboratory to
the other laboratory for quality control, internal quality control,
there would have to be well documented processes and data collected
for that quality control. Biopsy smear correlation would be imperative
in that situation so that the pathologist knew that patients that
he recommended be referred for colposcopy had been appropriately
referred, in other words, that the majority of these patients did
indeed have disease and that the biopsy reflected the disease he
suspected from his cervical smear report, and that he frequently
participated in external quality assurance, he frequently attended
meetings of cytologists with cytology topics pertaining to cervical
screening, and that he ensured that his laboratory met all external
accreditation procedures and processes that were available, and
even then I think there are major risks involved.
5.14 The risk of error when one person reads all the
cervical cytology was heightened by Dr Bottrill’s practice of cervical
cytology as he did not regularly adopt any of the measures which Professor
McGoogan outlined as essential to overcome the risks of a pathologist
acting on his own:
He had no internal quality control of the type
contemplated by Professor McGoogan;
He did not participate in any external quality
control programme;
Gisborne Laboratories was not accredited with
any independent accreditation authority;
It had no organised programme to correlate
a patient’s abnormal cytology results with the later discovery
of cancerous or pre-cancerous lesions by biopsy;
Dr Bottrill’s contact with other pathologists
and his attempts at continuing education were insufficient to
enable him to overcome the risks inherent in acting as a sole
practitioner in cervical cytology;
When Dr Bottrill was asked about the measures
which Professor McGoogan had outlined as necessary, if a pathologist
were to practise cervical cytology on his own, he was unable
to inform the Committee if his practices met these measures.
5.15 Dr Teague’s view of Dr Bottrill’s practice was
similar to that of Professor McGoogan. He described the practice as
suboptimal:
"Q Would you describe it as
an acceptable practice?
A I think it would be sub-optimal
the way it was done.
Q And why is that?
A Particularly for the reason that
there was only one person doing essentially both the primary and
secondary screening or rechecking. There was some evidence I believe
that Dr Bottrill did rescreen 10% of slides and there are statistics
which show in fact that if the same person rescreens a slide they
may get a different answer so to that extent there will be some
benefit from that, but I believe that it would not be the benefit
that one would expect to from getting a different pair of eyes to
look at it."
5.16 The Committee accepts the views that these witnesses
have expressed about Dr Bottrill’s practice. It agrees with the view
expressed by Professor McGoogan that a laboratory that employs one person
to carry out this task is providing a bad service. It considers that
the somewhat subjective nature of the task of reading cervical cytology
makes it too risky for one person to carry out, as misread smears are
less likely to be discovered. The Committee considers that the practice
followed at Gisborne Laboratories of having one person read the cervical
cytology is a factor that is likely to have led to the unacceptable
level of under-reporting that occurred at the laboratory.
Inadequate Internal Quality Control
5.17 In his evidence Dr Bottrill expressed the view
that quality control was something which played a greater role in large
laboratories and he saw no need for it in a small laboratory like Gisborne
Laboratories. The internal quality control that he employed consisted
of him, approximately once a week, re-reading 10% of the smear tests
that he had originally read as normal. He neither documented this exercise,
nor did he compare the re-read results with the original results. He
could not recall any occasion on which, when carrying out a random re-reading
of slides, he had discovered a smear test which he had originally read
as normal and which on rereading he found to be abnormal. Nor could
he remember a time when, on re-reading a slide, he became concerned
about his original report. Considering the number of under-reported
smear tests that have now come to light it seems surprising that the
10% random re-screening he carried out did not reveal any of these errors.
The Committee can only conclude that Dr Bottrill had "calibrated"
his eyes to read smear tests with a very high specificity and that on
any second view of a smear test he was only corroborating his original
error.
5.18 Apart from the 10% random re-screening there was
little else done in the way of internal quality control. In 1993 when
Gisborne Laboratories had applied for TELARC accreditation, work began
on a quality control manual; however, this work cannot have been taken
very far, or if it was it cannot have been effective as Medlab Hamilton
found it necessary to replace it with its own quality control manual
when it assumed control of Gisborne Laboratories.
5.19 Gisborne Laboratories had no organised programme
for correlating biopsy results with cytology results. Dr Bottrill’s
evidence was that he did keep records of cytology/ histology correlation
on the occasions when the histology was sent to him for diagnosis. However,
he accepted that where the biopsy was performed at the local hospital
he was unlikely to receive information about the histology result. There
was no formal communication between Gisborne Laboratories and the local
hospital which would have provided him with this information. If Dr
Bottrill had been able to conduct an organised programme correlating
histology with cytology this would have informed him of the accuracy
of his reading. It may have brought to his attention his false positive
rate and true positive rate which the Committee knows to have been too
low. Had Dr Bottrill realised his false positive rate was extremely
low that may have made him alive to the probability that he was "setting
the bar too high" and consequently under-reporting too many smear
tests. Had he realised his true positive rate was too low he would have
known that he was failing to recognise abnormal smear tests and reporting
them incorrectly as normal (false negatives). A programme of looking
back at a woman’s previous negative smear tests when she was found to
have a high-grade abnormality on histology to determine if those smear
tests were false negatives should have alerted Dr Bottrill to his under-reporting.
In the circumstances the Committee’s view is that at Gisborne Laboratories
correlation of histology with cytology occurred sporadically and was
not sufficient to produce the quality control benefits which come from
an organised programme of histology cytology correlation.
5.20 In the Committee’s view the internal quality control
followed at Gisborne Laboratories was inadequate. It did not meet the
expectations of internal quality control that Professor McGoogan outlined
in her evidence. Her expectations of internal quality control are consistent
with those of International Accreditation New Zealand (IANZ), the national
accreditation authority for quality assurance, laboratory testing and
industrial design. The Committee heard evidence from Mr Graham Walker
the former programme manager medical testing and radiology of IANZ on
the parameters of internal quality control. In Mr Walker’s view Dr Bottrill’s
internal quality control fell outside these parameters.
5.21 Mr Walker visited Gisborne Laboratories in 1993
when it had applied to the Testing Laboratory Registration Council (TELARC),
which formerly carried out IANZ’s functions, for accreditation. The
application did not proceed. During his visit Mr Walker noted the absence
of documented laboratory procedures and recorded that this was something
which Gisborne Laboratories would have to institute if it were to become
accredited. An additional aspect of internal quality control that IANZ
considered significant, and which was lacking at Gisborne Laboratories
was the ability to have a smear test checked by a second person. In
his brief of evidence to the Committee Mr Walker said:
"An important aspect of internal
quality control is the ability to release apparently normal slides
on the basis that a second person within the laboratory has re-screened
a proportion of those slides and validated the test results. Gisborne
Laboratories did not have such a second person. There was, therefore,
no internal quality check, as well as there not being any opportunity
for Dr Bottrill in the cytology/histology context to exchange ideas
with another cytopathologist. In such a circumstance there is extreme
pressure on the pathologist to get the test result right as there
are no other means to intercept problems and carry out frequent
and random checks on test results".
5.22 The Committee considers that the lack of adequate
internal quality control at Gisborne Laboratories is a factor that is
likely to have led to the unacceptable level of under-reporting that
occurred at the laboratory. Had the practices at Gisborne Laboratories
conformed with the internal quality control requirements outlined above
it is likely that the level of under-reporting which occurred would
have been detected sooner or perhaps avoided altogether.
Inadequate Systems And Procedures
5.23 Dr Bottrill’s views on quality control being more
suited to big laboratories may have coloured his opinion on the usefulness
to a small laboratory of organised systems and procedures in general.
The laboratory systems he followed had shortcomings: he had no procedure
in place to prevent a slide mix up, although there is no evidence this
had ever happened; he did not as a matter of routine carry out "look
back" exercises of a woman patient’s previous smear tests; he had
no system to inform him as to whether or not he had read a woman patient’s
previous smear tests, (this meant that unless he was told by the woman’s
smear taker that he had read her previous smear tests he had no way
of knowing whether or not there were previous smear tests to look back
on); he did not regularly get information about his female patients
from the National Cervical Screening Register.
5.24 The deficiencies in the systems and procedures
at Gisborne Laboratories would not have promoted a competent performance
in cervical cytology. The Committee considers that this is a factor
which, if not of itself, then certainly combined with the other factors
listed herein is likely to have led to the unacceptable level of under-reporting
that occurred at the laboratory.
No External Quality Control
5.25 Gisborne Laboratories did not participate in any
external quality assurance programme. Dr Bottrill did not appear to
place a high value on quality control. In his evidence to the Committee
he said:
Q Was it your view at the time that
measures such as external quality assurance and quality control
systems played no part in affecting your standard of smear reading?
A Yes
Q So you didn’t think they would
help your accuracy, is that right?
A I think that is correct, yes
Dr Bottrill said that he liased with a series of pathologists
who were employed at Gisborne Hospital. He said he visited the hospital
four or five times a week around lunchtime to have a general discussion
with the current hospital pathologist and to show him or her any slides
of interest or difficulty. He said that he maintained good collegial
relationships by doing this and he was also able to obtain second opinions
on difficult or interesting slides. However, he accepted that there
was not always a pathologist employed at the hospital, that there could
be periods of up to one year when nobody was there and that at those
times he was the only pathologist in Gisborne. The Committee considers
that the informal interaction Dr Bottrill had with the pathologists
at Gisborne Hospital was insufficient to remove or reduce the risk inherent
in practising as he did. It comes nowhere near the type of interactions
that are carried out for the purpose of external quality control.
5.26 Although the evidence shows that in 1991 there
was no entirely satisfactory external quality assurance programme available,
and it seems that was still so in 1993, the Royal College of Pathologists
of Australasia offered a programme which was a step in the right direction
and over the years this programme has developed and improved. The Committee’s
view is that participation in an external quality assurance programme
which is still in the early stages of development and which may not
be entirely satisfactory has benefit nevertheless, as it should make
a pathologist more alert to the possibility of error, and it should
cause a pathologist to focus more on the need to adopt measures to reduce
the risk of error occurring. The external quality assurance programme
which the Royal College of Pathologists of Australasia offered involved
a pathologist receiving slides from the College, reading them and reporting
the results to a central collating agency and subsequently receiving
reports which compared the reports of his or her slide reading with
the consensus view of the other pathologists who participated in the
programme. In this way a pathologist was able to learn whether or not
his or her reading of slides was within the average range or above or
below that range.
5.27 Participation in such a scheme may have alerted
Dr Bottrill to the likelihood that he was failing to recognise some
abnormal smears and consequently he was under-reporting the abnormalities
he was seeing. The Committee considers that the failure at Gisborne
Laboratories to ensure that the pathologist participated in an external
quality control programme is a factor that is likely to have led to
the unacceptable level of under-reporting that occurred at the laboratory.
No Accreditation With An Independent Quality Control
Authority
5.28 Throughout the time that Dr Bottrill was in practice
Gisborne Laboratories was not accredited with an independent laboratory
quality control authority such as TELARC. Even though the requirements
for TELARC accreditation were not as demanding in the early 1990s as
they are now, they still would have deterred Dr Bottrill from practising
as he did. Most importantly, from 1993 onwards, it seems that so long
as Gisborne Laboratories employed only one person to carry out all the
cervical cytology it would have been denied accreditation. Mr Walker
said in evidence:
Chair Question You have talked …
about the situation of Dr Bottrill doing all the cytoscreening on
his own, in terms of TELARC IANZ accreditation again looking at
it from 1993 to 1996, would TELARC accredit a laboratory where a
single pathologist was doing all the cytoscreening.
A Very definitely not. I have already
indicated …those three laboratories where their cytology accreditation
has been suspended, it is as a result of the loss of their last
cytotechnologist. So that a single pathologist however competent
would not meet our requirements of accreditation.
Q So … one of the things that Dr
Bottrill would have had to have done if he wanted to obtain accreditation
for the laboratory was to hire a cytoscreener to work with him.
A Or to make arrangements for another
pathologist to rescreen his work.
Q Yes.
PROFESSOR DUGGAN INTERJECTS
PROFESSOR DUGGAN: By that comment
Mr Walker, it is acceptable to TELARC that gynaecological slides
can be screened by a pathologist?
A Solely …by a single pathologist,
no.
Q Well no, screened by a single
pathologist with the quality control done by another pathologist.
A We would have considered that
as an option. It would have been unusual.…
A I don’t know of a pathologist
in New Zealand at the present point in time that would have absolute
confidence in his or her work without somebody else having reviewed
a good percentage of it, that someone else could equally be another
pathologist or a cytotechnologist.
5.29 In addition to ensuring that more than one qualified
person was involved in cervical cytology TELARC accreditation would
have led to improved systems and procedures at Gisborne Laboratories.
By May 1991 TELARC had issued recommendations, which had been formulated
by the Cytology Advisory Liaison Committee, and which TELARC intended
its assessors to discuss with laboratories during accreditation assessments
for cytology. These recommendations were not extensive, however, they
required:
a recommended process for checking abnormal
smear tests;
random rescreening of 10% of negative smear
tests;
they identified maximum annual and daily limits
for reading smear tests;
they encouraged participation in an external
quality control programme; and
they recommended the phasing out of off-site
(home screened) smear tests.
5.30 By June 1991 TELARC had issued the New Zealand
Code of Laboratory Management Practice. This document, which was produced
to the Committee as exhibit BJL/MEDH/5, set out requirements for laboratory
practice. These included having in place laboratory quality control
procedures; the purpose of which is to demonstrate that accurate and
reliable tests are being produced, to anticipate potential sources of
error in a laboratory’s operations and to implement checks at appropriate
control points to detect any errors that should occur.
5.31 Furthermore, from 1991 TELARC recommended that
laboratories accredited for cytology participate in an external quality
assurance programme. By 1993 participation in an external quality control
programme had become "virtually essential" for TELARC accreditation.
When asked to explain what "virtually essential" meant Mr
Walker described it as indicating a requirement which an assessment
team might impose on a laboratory. And although it was not an absolute
requirement in 1993 it was about to become so within a short period
of time, so that any laboratory which did not participate in an external
quality control programme in 1993 and which wanted accreditation would
have had to enrol in such a programme in the very near future if it
wanted to obtain or retain its accreditation. Mr Walker told the Committee
:
A Historically, in the absence of
an appropriate programme of inter-laboratory comparison, the requirement
of IANZ, TELARC in those days, for mandatory participation, was
not in existence but as those programmes became more and more developed
and more and more accepted by the industries participating in them,
they became progressively more likely to become requirements of
accreditation, the error that we are talking about here was at the
point where it was virtually a requirement, a few years before that
it would not have been a requirement and very soon after that it
became a mandatory requirement.
Q … so when you say virtually essential
you are meaning that this is something that in a very short period
of time is going to become essential and so you are signalling that
to the reader of the letter.
A That’s a very fair assessment
of what I intended to say, perhaps I should have used those sorts
of words.
Q And so your expectation would
be then that the reader takes that phrase at their peril and either
does something about it immediately or waits until it becomes an
absolute requirement and that that will happen very soon.
A I have every confidence that had
Gisborne laboratory taken the next step and been initially assessed,
that the peer assessment team would have required participation
in that programme and that was my intent and perhaps using the words
virtually essential doesn’t appropriately convey that intent.
5.32 Accreditation does not guarantee that laboratories
will not under-report an unacceptable number of smear tests. It focuses
on the systems and procedures a laboratory uses to achieve its results
and not on the substance of the results. What it does is set in place
systems and procedures to ensure that a laboratory has appropriately
trained staff, well maintained equipment and recognised methods and
procedures in place. However, if these systems and procedures are properly
followed they should enhance a laboratory’s performance substantively
as well as procedurally as they are likely to lead to good quality results
and to reduce the opportunities for error.
5.33 Accreditation also creates a culture and an awareness
of quality assurance and the benefits to be derived from it. A laboratory
which is attuned to the need for quality assurance to improve work performance
is less likely to produce errors in smear test reporting than a laboratory
where the need for quality assurance is unrecognised. Moreover, the
process of obtaining accreditation involves subjecting a laboratory
to a full review by a team of experts in the field for which accreditation
is sought and thereafter regular inspections. This degree of attention
would be likely to bring any risk associated with a laboratory’s performance
to notice.
5.34 Had Gisborne Laboratories been accredited with
TELARC by the end of 1991 the impact of the CALC inspired recommendations
and the New Zealand Code of Laboratory Management Practice combined
with the employment of a second person to share the reading of cervical
cytology would have improved the systems and the procedures Dr Bottrill
followed and this in turn is likely to have reduced his under-reporting
to a more acceptable level. Certainly by 1993 accreditation with TELARC
would have resulted in improved systems and procedures including the
introduction of internal and external quality control and a requirement
to share the task of reading cervical cytology with another person.
It would have brought to an end the practices that the Committee considers
are likely to have led to the unacceptable level of under-reporting.
The Committee, therefore, considers that the laboratory not being accredited
is a factor that is likely to have led to an unacceptable level of under-reporting.
Inadequate Participation In Continuing Medical Education
5.35 Dr Bottrill’s specialist training was in anatomical
pathology. He was appropriately trained in cytopathology given the standards
of the time during which he trained, however at that time cytopathology
was in its infancy. Since then, cytopathology has evolved and grown,
and the practice has become more specialised. Dr Bottrill informed the
Committee that he had no specialist qualification in cytology; the examination
he sat in the early 1970s to become a member of the College of Pathologists
of Australia had no cytology component. Dr Bottrill’s qualifications
and experience can be contrasted with recommendations contained in standards
the Cervical Screening Liaison Advisory Committee (CSLAC) sent to TELARC
in 1995. These standards reveal how the perceived need for pathologists
to have training in cytology had increased. They contain a recommendation
that pathologists wishing to practise in cytopathology should have a
minimum of two years special supervised training. Those pathologists
who have the qualifications in anatomical pathology but who lack expertise
in cytopathology are advised to undertake appropriate training prior
to taking responsibility for cytological reporting in New Zealand laboratories.
5.36 Competence in a changing field is maintained by
undergoing additional formal training in an accredited training centre
and/or through participation in continuing medical education activities.
Dr Bottrill did not undergo additional training. Dr Bottrill’s
evidence was that he continued his medical education by: attending approximately
six to eight local post graduate meetings per year; biannual attendances
at conferences and workshops relating to cytology and histology; attending
the cytology sessions of the Royal College of Pathologists of Australasia
between the years 1968 to 1993; attending a conference in Mexico of
the World Association Society of Pathology in 1993 and a conference
by the same organisation in Auckland in 1995; and attending the New
Zealand Society of Cytology meetings on numerous occasions, the last
being in 1992. He also spent time reading in the library at Gisborne
Hospital. It seems from the evidence the Committee heard that Dr Bottrill’s
participation in continuing education began to decline in 1993. Furthermore,
his participation at the conferences and workshops he did attend does
not appear to have made him realise or gain any insight into the risk
he was taking by practising as a sole practitioner in cervical cytology,
nor did it improve his reading of cervical smear tests.
5.37 The Committee considers that the degree to which
Dr Bottrill participated in medical conferences and workshops in the
period from 1990 to 1996 was insufficient for him to improve his cytopathology
practices. He could have done so by additional formal training, however
he never underwent such training. In the Committee’s view more focussed
continuing medical education and additional formal training in cytopathology
would have brought home to Dr Bottrill the danger inherent in the practices
followed at Gisborne Laboratories, and the need to reform the laboratory’s
practices. For this reason the Committee considers that the failure
of Dr Bottrill to participate in continuing medical education is a factor
that is likely to have led to the unacceptable level of under-reporting
that occurred.
Lack Of Awareness And Insight As To How The Laboratory’s
Practices Put Patients At Risk.
5.38 The Committee considers that another feature of
the practice of cervical cytology in Gisborne Laboratories, which was
not compatible with the effective or safe delivery of cervical cytology,
was that Dr Bottrill had no awareness of or insight into the extent
to which the laboratory’s practices put patients at risk. In his evidence
to the Committee he said:
"I think if I were doing it
again I wouldn’t make any major changes. I was completely unaware
at the time that I retired that there was a problem".
5.39 This lack of awareness and insight as regards the
risk inherent in his practice of cervical cytology probably explains why
Dr Bottrill continued to read cervical cytology on his own until his retirement
in March 1996, and why he failed to have in place any measures to reduce
the risk of practising in this way. Dr Bottrill’s view on his practice
at Gisborne Laboratories is completely at odds with the evidence the Committee
has heard from experts on how a laboratory should carry out cervical smear
test screening and the inherent dangers when carried out by a sole practitioner.
He refused to accept that the following features of his practice contributed
to his under-reporting:
his lack of expertise in cytopathology and primary
screening;
his lack of appropriate continuing education;
the laboratory’s failure to take timely steps to
get accredited;
the laboratory’s failure to institute appropriate
internal and external quality control;
the laboratory’s failure to institute a system of
peer review; and
the laboratory’s failure to have systematic look-back
procedure for patients.
This attitude of Dr Bottrill only confirms for the Committee
his unawareness of and lack of insight into the risks his practice posed
to patients.
Factors Relating To The Delivery Of Cytological Services
In New Zealand Between 1990 And March 1996
5.40 From the years 1990 to 1996 cytological services
in New Zealand were delivered in circumstances where:
Laboratories reading cervical cytology were not required
to follow quality control processes or to be accredited with an independent
quality control authority;
The Government Policy for National Cervical Screening
(1991) and the 1993 updated version in relation to laboratories
reading cervical cytology were not well designed;
The National Cervical Screening Register was not
functioning optimally;
There were no performance standards for laboratories,
and there were no reliable data on laboratories’ performance;
There was no monitoring and evaluation of the performance
of laboratories reading cervical cytology;
The health authorities did not take heed of the warnings
provided by the failures of screening programmes in other countries;
There was a failure to ensure all components of the
programme where in place from an early stage.
All of this is indicative of a failure to design and
deliver a soundly based cervical screening programme. The Committee
has already identified the factors relating to the practice of cytology
at Gisborne Laboratories that it considers are likely to have led to
the unacceptable level of under-reporting that occurred at that laboratory.
The Committee considers that but for the failure to deliver a soundly
based cervical screening programme the cytology practices at Gisborne
Laboratories could not have continued for as long as they did. If the
factors, which the Committee considers the Programme lacked, had been
operative the practice of cervical cytology at Gisborne Laboratories
would have been improved or come to an end. Either way the risk of unacceptable
under-reporting would have been considerably reduced. Thus the Committee
considers that the failure to deliver a soundly based cervical screening
programme is a factor that is likely to have led to the unacceptable
under-reporting that occurred in the Gisborne region. The Committee’s
reasons for reaching this view are set out below.
No Compulsory Quality Control
5.41 Compulsory quality control including accreditation
for all laboratories reading cervical cytology was not introduced until
some time in late 1996. It is difficult to be precise about when these
requirements were introduced as their introduction into individual laboratories
was achieved at different times and through more than one mechanism.
What is clear is that before this time quality control (and accreditation)
was not mandatory, even though the need for quality control of laboratories
reading cervical cytology for a cervical screening programme was seen
as essential by more than one authoritative source from as early as
the mid- nineteen eighties. A review of some of the authoritative material
is set out below.
5.42 The 1986 Bulletin of the World Health Organisation
on Control of Cancer of the Cervix Uteri recognised the need
for quality control to reduce the occurrence of false negative reports.
It said:
" Quality control systems must
be developed in cytology laboratories to keep the number of
false negatives reports as low as possible." (Emphasis added)
5.43 In 1988 a Department of Health publication titled
Towards a More Effective Cervical Screening Service for Women recognised
the need to develop quality control measures in laboratories reading
cervical cytology. It said that:
" A review of laboratory services
for cervical cytology is required. This review will need to include
the development of quality control measures to ensure that cytological
services in laboratories maintain a consistently high standard."
In its submission to the Committee the Ministry of
Health said that this publication demonstrated that the Department of
Health was "well aware of the issues surrounding quality relating
to a national [screening] programme, including the key issues surrounding
quality in laboratories."
5.44 In November 1989 the Report Of The Ministerial
Review Committee On Implementation Of A Government Policy for National
Cervical Screening was published. Section 8 of the report covered
smear readers and standards of competency. It began by noting that:"
Laboratories and their staff will play a key role in the success of
any cervical screening programme, as it is principally through them
that cytological information will be collected and recall dates established."
Sections 8.10-8.13 set out the importance of quality controls to ensure
consistency in the reporting of cervical smears.
5.45 In July 1990 Dr Judith Straton of Division of
Public Health University of Western Australia was engaged by the Department
of Health to review of the National Cervical Screening Programme. She
produced a document titled Review of the Government Policy for National
Cervical Screening in which review she wrote:
"Aspects of the laboratory
services which need attention include accreditation and quality
control. …It seems that the accreditation
of laboratories by the national laboratory accreditation organisation
(TELARC) is on a voluntary basis and only a relatively small number
of laboratories are accredited. I have not seen the criteria for
accreditation used by TELARC but I understand that they do not at
present cover all the necessary areas. I believe that there should
be a system of accreditation of laboratories carrying out cervical
cytology screening, which is tied to the reimbursement of laboratories
for reading smears. Public hospital laboratories should also be
included." (emphasis added)
5.46 In August 1990 an experts groups which had been
established in December 1989 to advise the Minister of Health on national
policy and resource allocation for the National Cervical Screening Programme
presented a report titled Policy Statement Of The Government Policy
for National Cervical Screening Expert Group. Section 12 of the
report dealt with laboratories. The report acknowledged that: "The
efficiency of the cervical screening programme will depend on high standards
of smear reading by laboratory technicians and an acceptable turn-around
time for reporting on smears. " In section 12.2 the report set
out a proposed implementation strategy for the programme in relation
to laboratories. This provided:
"Section 12.2.2 The expert group
recommends that by 1991 all cytology laboratories serving the National
Cervical Screening Programme should have applied for registration
with the testing Laboratory Registration Council of New Zealand
(TELARC) and should be TELARC registered by December 1993. The only
exceptions will be if TELARC itself is unable to meet these deadlines
or if a laboratory is newly set up, necessitating a reasonable period
of time in which to obtain TELARC registration.
12.2.3 The Department of Health should
be responsible for confirming that those laboratories carrying out
cytology screening for the National Cervical Screening Programme meet
the recommendations set out in 12.2.2. Such confirmation should become
a requirement for receiving the laboratory benefit for reading National
Cervical Screening Programme smears.
12.2.4 The criteria for registration
by TELARC should be negotiated with TELARC by CALC and the Department
of Health. The criteria will include guidelines on :
The reading of a minimum number
of smears a year;
The employment of adequate numbers
of suitably qualified staff;
The maximum workload for each
cytoscreener;
Adequate in-service education;
A satisfactory participation of
both internal and external quality assurance procedures;
Co-operation in providing cytology
reports to the cytology register.
12.2.5 The Department of Health, CALC,
TELARC and other relevant organisations will seek standards for the
training of cytology laboratory assistants. The Department of Health
is responsible for ensuring that there are sufficient training facilities
to meet the cytology screening workforce requirements of the National
Cervical Screening Programme.
12.2.5 Developing a mechanism for
linking the histology results of cervical tissue submitted to laboratories
for diagnosis to the cytology register is an urgent priority for the
Department of Health. The register will also be developed so that
laboratory staff have direct access to a woman’s previous smear history
when reading smears.
5.47 In July 1991 a report was published in the New
Zealand Medical Journal titled Cancer Screening 1991 Cervical Screening
Recommendations: A Working Group Report. The report commented on
the need for quality control of all aspects of cervical screening including
laboratory performance:
" Quality control of all
aspects of cervical screening should be a major emphasis of the
National Cervical Screening Programme. To provide proper quality
control there should be formal evaluation of all the components
of the screening process from recruitment and recall of women to
management of women with abnormal smears. A national register is
the essential management tool to allow this and should be expanded
to include the relevant histology results ensuring correlation and
evaluation of cytology findings. Health educators, smear takers,
laboratory staff, computer staff, colposcopists and therapists should
all be appropriately trained and qualified. Laboratories and
sites for therapy should be accredited . Legislation is essential
to allow all laboratories to provide both cytology and histology
results to the register."(emphasis added)
5.48 In 1991 the Government Policy For National
Cervical Screening (1991) was issued. This was the first written
policy for the Programme. It was prepared by the Department of Health
and approved by the Associate Minister of Health. The Policy was
based on the recommendations that were made in the August 1990 report
of the Expert Group. Part 4 of the Policy defined the role of
laboratories in the implementation of the Programme and the expectations
of their performance in this role. Part 4 incorporated most of the recommendations,
for quality control of laboratories, that appear in section 12 of the
Expert Group’s report. It anticipated laboratories being accredited
with TELARC or a similar authority by 1993; and it described the criteria
for accreditation. This included: having a set minimum number of smears
for reading each year; employing adequate numbers of suitably qualified
staff; having maximum workloads for each cytoscreener; making provision
for adequate in-service education; participating in internal and external
quality assurance procedures and providing cytology reports to the cytology
register.
5.49 It seems that pathologists were not in general
resistant to compulsory accreditation. The minutes of a meeting of the
Cervical Screening Advisory Committee held on 12 December 1991
record the committee’s discussion on how to enforce accreditation of
laboratories. Dr Clinton Teague, pathologist, is recorded as saying
that he did not think that accreditation would be a big problem as most
laboratories were moving towards accreditation, and that compulsory
accreditation had been accepted by laboratories as they had had sufficient
time to gain accreditation. He is also recorded as referring to the
Australian position where laboratories had to be accredited to claim
Medicare subsidies. The Committee has not seen any material or heard
any evidence in the course of its inquiries that would suggest that
pathologists would have strongly resisted the introduction of compulsory
accreditation by making receipt of government funding conditional on
accreditation.
5.50 In 1992 the World Health Organisation published
the Cervical Cancer Screening Programmes’ Managerial Guidelines. In
discussing technical resources for cytological examination the guidelines
state :
"Before a screening programme
is started the resources must be in place for taking the smears
and a cytology laboratory must be accessible to examine and report
on the smears. To ensure that the laboratory services are both efficient
and cost effective they should be centralised, each laboratory being
supervised by a fulltime cytolopathologist with an organised
system of quality assurance and continuous education of cytotechnologists.
(emphasis added)
Later in the Guidelines there is a reference
to an earlier World Heath Organisation publication of 1988 dealing with
laboratories in which it was recorded that: " The laboratory must
have adequate quality control procedures in place for cervical cytology."
5.51 All of the above shows that at an early stage
in the development of the Nation Cervical Screening Programme there
was authoritative material from international and national sources on
the importance of quality control in laboratories reading cervical cytology
for screening programmes. The various reports to the Minister and the
Department on the establishment of a cervical screening programme all
recognised the importance of quality control. Furthermore, the inclusion
of quality control provisions in the Policy in 1991 shows that
by then the Minister and the Department had accepted quality control
was important. Moreover, the Committee was not referred to any material
which suggested that the use of quality control processes in laboratories
reading cervical cytology was unnecessary.
5.52 The Committee’s view was confirmed by the evidence
of Professor McGoogan. She was critical of the failure to have quality
controls in place from the outset. She was shown a flow diagram that
was appended to the draft report of the National Cervical Screening
Workshop of 1988. This flow diagram recorded the points in the Programme
at which quality control and evaluation needed to occur. Professor McGoogan
considered the diagram was a good starting point for implementing quality
control, but that it did not go far enough. When asked to give her opinion
on the Programme’s failure to adopt the diagram of quality controls
and its lack of any quality controls on laboratory performance up to
1996 her response was:
" I would be extremely disappointed
because by the time the New Zealand Programme was implemented
the need for quality control and evaluation for a screening programme
of any kind was well recognised.
Professor McGoogan considered that if quality controls
were not in place from the outset that they should have been in place
by the end of the first cycle of the programme, that is: three years
after its commencement and for good data to be collected from that time
onwards.
5.53 It seems to the Committee that the necessity of
quality control processes for reading cervical smear tests for a screening
programme is incontestable. This is not an idea that has only recently
become accepted. The literature to support this view has been available
for many years and certainly some of it pre-dates the National Cervical
Screening Programme. Furthermore the logic of the necessity for quality
control is readily apparent. One significant difference between laboratory
diagnostic testing for a screening programme and laboratory diagnostic
testing to discover a suspected ailment is that in the latter case the
patient is unwell and presents with signs and symptoms. Because the
patient is unwell there is bound to be further investigation, if the
laboratory misdiagnoses the test, and this should ultimately lead to
the correct diagnosis. None of this applies to a screening programme.
A screening programme involves large numbers of healthy women. The whole
purpose of a screening programme is to detect pre-cancerous abnormalities,
which are generally asymptomatic. This means that a woman who is referred
for a cervical smear test will usually not be displaying any signs.
If her smear test is misdiagnosed there is nothing to alert her or her
medical practitioner to that possibility. It, therefore, seems obvious
to the Committee that there are, and always have been, more pressing
reasons for having quality control processes in laboratories reading
cervical cytology for screening programmes than in respect of other
diagnostic services. So that, even though during the period under review
general laboratory services were not subject to compulsory quality control
or accreditation requirements, there was good reason to treat cervical
cytology differently. Compulsory quality control and accreditation of
laboratories reading cervical cytology should have formed part of the
National Cervical Screening Programme from the outset. The Committee
understands that some laboratories could not have become accredited
immediately. However, those laboratories could have been accommodated
by specifying a lead-in period with a definite expiry date after which
only accredited laboratories would be eligible to receive funding for
reading cervical cytology.
5.54 In 1993 the Policy was updated to accommodate
the structural changes in the health sector. Part 4.1.2 which set out
the expectation that laboratories would gain TELARC accreditation by
1993 was amended by removing the indirect reference to this date and
replacing it with an expectation that accreditation should be achieved
within a reasonable period of time. This weaker statement placed less
pressure on laboratories than the earlier expectation, which at least
attempted to place a time limit on the move towards accreditation. At
the same time in 1993 the European Community had issued guidelines on
cervical screening which recognised the importance of quality control
in laboratories. Section 7 of the European Guidelines For Quality
Assurance In Cervical Cancer Screening, which covers quality
assurance in the cytology laboratory, stated:
"Quality assurance in cervical
cytology is designed to achieve an acceptable reliability and consistency
in the results produced in the cytology laboratory."
Then after defining the terms "internal quality
assurance" and "external quality assurance" the Guidelines
continued: "We consider that both schemes are essential for
sound laboratory practice "(emphasis added). The Guidelines
also recognised the need for accreditation of laboratories with an independent
quality control agency:
"Accreditation is assessment
of standards by a panel of experts. The assessment will entail a
visit to the laboratory to inspect working conditions and assess
working practises such as staff workload ratio, quality assurance
measures, health and safety preconditions, arrangements for staff
training, quality of record keeping, arrangements for follow up
of abnormal smears etc"
5.55 It was not until late 1996 that compulsory accreditation
for cervical cytology was imposed; and then it occurred in a piecemeal
fashion as each of the four Regional Health Authorities was able to
conclude a contract (including compulsory accreditation) with the diagnostic
laboratories which provided it with services. In the case of the Gisborne
region the service contract between Midland Regional Health Authority
and Gisborne Laboratories, was not executed until March 1997. This was
nine years after the Department of Health had first recognised the need
to develop quality control measures to ensure laboratories reading cervical
cytology maintained a high standard.
5.56 The Ministry of Health has submitted to the Committee
that there are good reasons why it took so long to introduce compulsory
quality control through requiring laboratories to be accredited with
IANZ or a similar body. These reasons and the Committee’s views on them
are dealt with in the discussion on Term of Reference Three, which looks
at systemic problems with the National Cervical Screening Programme.
For the purpose of answering Term of Reference Two the Committee considers
that it is necessary only to report on those factors that it considers
are likely to have led to under-reporting. The Committee has already
described the benefits of quality control and laboratory accreditation
and the effect they would have had on the practice of cervical cytology
at Gisborne Laboratories. Because it considers that compulsory quality
control (either through TELARC accreditation or a scheme with similar
features which the Department imposed directly as a condition of payment)
would have prevented Gisborne Laboratories from continuing to practise
as it did, the Committee has concluded that the failure to make quality
control and laboratory accreditation compulsory by 1993, at the latest,
is a factor that is likely to have led to the under-reporting in the
Gisborne region, 1993 being the chosen year in the 1991 Policy
for laboratories to have gained accreditation. The Committee is aware
that mistakes can still occur in accredited laboratories, and that accreditation
is not a complete answer to avoiding laboratory errors. In this case,
however, accreditation would have stopped those practices at Gisborne
Laboratories that led to unacceptable under-reporting.
Design Faults Of The Government Policy For National
Cervical Screening (1991) As It Related To Laboratories Reading Cervical
Cytology
5.57 The laboratory component of the 1991 Policy
and the updated 1993 version was set out in clause 4 of both
documents. It was much the same as the recommendations for laboratories
reading cervical cytology in section 12 of the Expert Group’s report
of 1990. Clause 4 provided
"4.1.2 All cytology laboratories servicing the
National Cervical Screening Programme should be registered with the
Testing Laboratory Registration Council of New Zealand (TELARC)
or other recognised authority. It expected that laboratories not so
registered will apply and gain such registration. A reasonable period
of time will be allowed for laboratories to obtain registration. This
may take up to two years.
4.1.3 The Department of Health will be responsible
for confirming that those laboratories carrying out cytology screenings
for the National Cervical Screening Programme meet the requirements
set out in 4.1.4.
4.1.4 The criteria for registration
by TELARC or other recognised authority will be established by the
cytology advisory liaison committee. The Department of Health will
be consulted. The criteria will include :
Reading of a minimum number of smears
a year;
Employment of adequate numbers of
suitably qualified staff;
Maximum workload for each cytoscreener;
Adequate in-service education;
Satisfactory participation in both
internal and external quality assurance procedures;
Provision of cytology reports to
the cytology register.
4.1.5 The Department of Health, the
Cytology Advisory Liaison Committee, TELARC and other relevant organisations
will monitor standards for the training of cytology laboratory assistants."
5.58 The Committee has already discussed in the preceding
paragraphs the importance of quality control, including laboratory accreditation.
Here, the focus of the Committee’s interest is on the special accreditation
for laboratories reading cervical cytology that was planned in clause
4 of the Government National Cervical Screening Policies issued
in 1991 and 1993. The clause specified a number of criteria for inclusion
in TELARC’s general criteria for accreditation. These were additional
criteria which the Policy intended the Cytology Advisory Liaison
Committee (CALC) to develop in consultation with the Department and then
for TELARC to apply them when it came to accreditation of laboratories
reading cervical cytology. Clause 4 demonstrates the Policy’s intent
to shape the criteria for TELARC accreditation for laboratories reading
cervical cytology to include requirements which had been recognised overseas
as being beneficial to the success of a screening programme. Three paragraphs
of clause 4 are significant; these are:4.1.2; 4.1.3 and 4.1.4
5.59 Though the inclusion of clause 4 demonstrates that
the Minister and the Department recognised the importance of quality control
for laboratories, and that the intent of the Policy was for laboratories
servicing the Programme to be accredited with an independent quality control
authority, the poor design of the Policy did nothing to guarantee
that occurred. Paragraph 4.1.2 did no more than to state that laboratories
"should be" registered with an accreditation authority.
This is different from stipulating that laboratories must be accredited.
There is nothing in the language of paragraph 4.1.2 that compelled the
Department to ensure a laboratory became accredited. The paragraph does
no more than exhort laboratories to gain accreditation. In the Committee’s
view, once the importance of accreditation was accepted, and provision
made for it in the Policy, the design of the Policy should
have ensured that accreditation would happen.
5.60 In the 1991 Policy paragraph 4.1.2 contained
an expectation that laboratories that were not accredited would be given
a reasonable period of time to do so, (up to two years). This expectation
was ineffective. If laboratories resisted or were dilatory in taking steps
to gain accreditation there was nothing that the Department could do under
the Policy, or otherwise, to compel them to become accredited.
This was so, even though diagnostic laboratories reading cervical cytology
were fully paid for this service from government funds. The Committee
comments in its report on Term of Reference Three on the Ministry of Health’s
explanation for how this came about. What the Committee is concerned to
report on here is its view that a well designed cervical screening policy
is one which recognises the need for quality control and accreditation
of laboratories and is designed to ensure these features are in place.
The 1991 Policy could not do this. This is one of the reasons why
the Committee considers the 1991 Policy to be poorly designed.
Compulsory accreditation, based on the criteria in paragraph 4.1.4, would
have brought the practices followed at Gisborne Laboratories to an end.
In so far as the Policy permitted Gisborne Laboratories to continue
to practice its poor design is a factor that is likely to have led to
the under-reporting at Gisborne.
5.61 The criteria in 4.1.4 are important. For example:
the criterion regarding a minimum number of smears per annum. In 1991
and up to the time of Dr Bottrill’s retirement Gisborne Laboratories was
reading no more than 5000 smears per year. At the time the internationally
recommended minimum number was well in excess of this number. The World
Health Bulletin on Control of Cancer of the Cervix Uteri had stated
in 1986 that:
"Cytology services should be
centralised. A large volume of work contributes to the successful
operation of a cytology laboratory because a specialised division
of labour is possible and a large number of abnormal smears representing
various pathologies will help to maintain the cytotechnologists skills.
In general laboratories that screen fewer than 20,000 specimens annually
are not cost-efficient and cannot support either a training programme
or a full-time cytotechnologist Preferably the annual number of specimens
should be 50,000 or more.
A publication from the Council On Scientific Affairs,
American Medical Association JAMA 1989 Quality Assurance In Cervical
Cytology( exhibit RGB/MOH/3) reported that the American Society
of Cytology would only accredit laboratories that received a minimum of
10,000 gynaecologic smears per annum or maintained staff of at least one
cytopathologist and one full time cytotechnologist.
5.62 In the Review of the National Cervical Screening
Programme, which was written in 1990, Judith Straton reported on
the need for setting a minimum number of smear tests. She saw no practical
difficulty in implementing this requirement as she considered that smear
tests could be easily transported to those laboratories which were reading
a large number of smears and which could meet a compulsory minimum requirement.
She realised that a compulsory minimum number would exclude some laboratories
from reading cervical cytology but it appears to the Committee that in
her view this would only benefit the Programme. She said:
" The issue of the minimum number
of screening smears which are essential to maintain a competent screening
service is one which needs to be addressed. Apparently there are laboratories
in New Zealand which are reading fewer than 50 smears per year, compared
with the minimum in the Untied Kingdom of 15-20,000 smears
per year. Obviously with a smaller and more scattered population one
may not be able to use quite such stringent criteria, but communications
in New Zealand are good and smears can easily be sent from place to
place. This problem needs to be addressed urgently. It would
be very difficult for laboratories reading as few as 50 smears per
year to maintain a suitable level of competence or have any systematic
quality control, and this issue must be faced. Women have the
right to expect a minimum level of competence in the reading of their
smears."(emphasis added)
5.63 From the material the Committee has seen it is clear
that everyone working with the Programme thought, in principle, that a
compulsory minimum number of smears was needed to maintain screeners’
competence. And, that 5000 smears per annum was a low number of smears
to read in order to maintain competence. However, by setting a minimum
number the Programme would have excluded some laboratories, including
hospital laboratories, from reading cervical cytology. In New Zealand
cervical cytology had always been read by any laboratory that wanted to
do so. Furthermore, there was no history of the Department or the Ministry
of Health preferring certain laboratories to others when it came to funding
for diagnostic services. Therefor, the setting of a minimum number required
a major change in approach. It seems to the Committee that ultimately
the issue was too difficult to face and nothing was done, even though
the Policy intended a minimum number of smears to be set and everyone
recognised the benefits of laboratories which read a large number of smear
tests. Once again the Policy had no means of ensuring that its
intent was achieved.
5.64 The issue of setting a compulsory minimum number
of smears for reading per year was finally faced in 2000 by the Health
Funding Authority when, in its proposed standards for laboratories reading
cervical cytology, it proposed a minimum of 12,000 smears per year. The
rationale behind setting a minimum number of smears per annum is that
unless a laboratory processes a sufficient number of smears the screeners
cannot maintain their competence. Simply by ensuring that a set minimum
number of smears for reading each year (which reflected international
minimum numbers) was actually in force the Policy would have excluded
Gisborne Laboratories from reading cervical cytology.
5.65 Clause 4.1.3 placed the responsibility on the Department
of Health to confirm that laboratories carrying out cytology reading for
the policy met the requirements of 4.1.4. However, as accreditation was
not compulsory clause 4.1.3 had little effect, and the evidence is that
the Department of Health did little to ensure that laboratories met the
requirements set out in 4.1.4.
5.66 The Committee heard evidence from Mr Mules,
the former Chief Executive of the Midland Regional Health Authority. He
had previously been employed as the General Manager of the Bay of Plenty
Area Health Board. In this capacity he would have had experience of how
the Policy of 1991 worked in relation to area health boards. He
had also undertaken work for the Health Reforms Directorate of the Department
of Health. He appeared to the Committee to be a witness who was informed
about the Programme and how it functioned prior to the health restructuring
in 1993. He told the Committee that one of the aims of the Programme prior
to 1993 had been to introduce quality standards for laboratories reading
cervical cytology but that the method by which such standards would be
enforced was unclear to him as in his view there was no appropriate accountability
structure in place:
"One of the aims of the National
Cervical Screening Programme was to introduce quality standards around
the reading of slides by pathologists, a process that requires the
pathologist to exercise their professional judgement after actually
viewing the slide and cannot be automated. Those aims were explained
under the heading "Laboratories" at page 5 of the
1991 Policy". …
Mr Mules then referred to the 1991 Policy, which stated
that the Department of Health would be responsible for confirming that
laboratories carrying out cytology screening met TELARC requirements and
said:
"To my knowledge this was the
first time that an attempt was made to have private laboratories agree
with an external agency (in this case Department of Health) to develop
and implement quality standards. How this is to be enforced in
the absence of an appropriate accountability structure is unclear."
(emphasis added)
5.67 Mr Mules evidence on the 1991 Policy confirms
for the Committee the impression it gained from other evidence that the
1991 Policy was designed without any provision put in place to
enforce the Policy, should the need arise. The overall tenor
of the Policy as regards laboratories is to set out statements
that essentially describe good practice and then to leave it to the good
will of the laboratories to respond to these exhortations. In the Committee’s
view this is insufficient. A well designed Policy should require
laboratories to practise quality control and to be accredited with an
appropriate authority, and it should ensure that there is a means of compelling
laboratories to comply with the Policy’s intent if they fail to
respond.
5.68 When the Policy was updated in 1993, to take
into account the structural changes in the delivery of health services,
the amendments to clause 4 only exacerbated its poor design. It has already
been noted in the report that the two year time frame within which accreditation
was expected to be achieved was removed. More importantly, the
division of responsibility in the updated Policy between the new
Ministry of Health, (which had replaced the Department of Health), and
the four new Regional Health Authorities, (which had assumed much of the
Department of Health’s operational responsibilities), was poorly designed.
This was so even though the updated Policy described itself as
being:
" revised and updated to accurately
reflect the structural changes to the health sector, the changes to
the National Cervical Screening Programme and Register… The purpose
of this revision is to update the policy for regional health authorities,
the Public Health Commission and for cervical screening programme
managers and service providers. The update makes no changes to the
goals, objectives, or targeting sections of the 1991 policy document."
The wording of clause 4 remained the same except that
the Ministry of Health was substituted for the Department of Health and
the statement in clause 4.1.2 that TELARC accreditation may take up to
two years was removed. No account appears to have been taken of the new
policy-making and advisory role of the Ministry and its reduced ability
to carry out operational activities. This change from a government department
to a ministry with a policy-making role meant that the new Ministry of
Health was less well placed than the Department of Health to carry out
the role clause 4.1.3 gave to it.
5.69 The Ministry did consider whether it was appropriate
for the Programme to remain with the Ministry, given its role in the new
health structure. An internal memo of 18 March 1993 from Sonja Easterbrook-Smith
to the Director-General acknowledges that the role of nationally co-ordinating
the Programme was anomalous in a policy advice Ministry. Nevertheless,
a decision was made to retain that role, and the responsibilities the
Policy of 1991 had imposed on the Department of Health, within
the Ministry. Once a decision was made to retain those features of the
Programme within the Ministry, the 1993 updated Policy should have
been designed to ensure that the effective delivery of the Programme was
not compromised by any resulting anomaly.
5.70 Ms Judith Glackin, who gave evidence for the Ministry
of Health, told the Committee that the Ministry could not carry out the
role of confirming that laboratories met the criteria in 4.1.4 as the
Ministry had no means of discharging this task. She said that the Ministry
sought, instead, to discharge this task by ensuring that laboratories
were TELARC accredited:
"Paragraph 4.1.3 could be read
as intending that the Ministry would in some way be responsible for
confirming that laboratories were meeting all the criteria required
for TELARC registration. This was clearly not possible, as the Ministry
had no direct relationship or influence over laboratories after RHA
[ Regional Health Authority] contracts replaced the previous payment
arrangements under Part II of the Social Security Act 1964. Ensuring
that laboratories were accredited by TELARC or another suitable quality
assurance programme was seen as the way of ensuring that laboratories
met quality standards.
However, the evidence shows that the Ministry did nothing
to ensure that laboratories were TELARC accredited. All that it
did was to include in its funding agreements with the regional health
authorities a provision that they use " reasonable endeavours to
ensure" laboratory accreditation. To ensure something is done is
to make certain, to secure or to guarantee that it is done. Requiring
regional health authorities to use their "reasonable endeavours to
ensure accreditation" does not amount to making certain, guaranteeing
or securing accreditation. Thus the Ministry failed to discharge its responsibilities
in clause 4.1.3, however that clause may be interpreted.
5.71 The Ministry’s inability to perform the role clause
4.1.3 placed upon it was recognised by the Cytology Liaison Advisory Committee.
In June 1994, when the 1993 Policy was being reviewed, this committee
commented in a submission for the review that:
"The Ministry of Health does
not have the expertise and nor would it seem an appropriate function
of the Ministry of Health to confirm that laboratories were meeting
detailed requirements relating to TELARC accreditation."
However, because of delays in the completion of the policy
review the wording in the 1993 Policy remained unchanged until
a new Policy document was issued in June 1996. This was after Dr
Bottrill’s retirement.
5.72 Ms Glackin referred to the 1994/95 Funding Agreements
between the Ministry and the Regional Health Authorities which required
the authorities to use their "reasonable endeavours to ensure"
that all laboratories providing laboratory services for cervical cytology
and histology were registered with TELARC or an equivalent quality assurance
programme. She said that these funding agreements were between the Minister
and the Regional Health Authorities and that they were "the primary
accountability documents".
5.73 All the funding agreements from 1994 until 1997/98
refer to the 1991 Policy, even though that Policy was based
upon a health structure of a Department of Health and 14 area health boards.
The Committee received no explanation for why the funding agreements referred
to the 1991 Policy. Although the 1993 Policy had been updated
to make specific reference to the new health structure involving the Ministry
of Health and the regional health authorities the funding agreements failed
to record this. By the 1997/98 funding agreement a new policy had been
published in 1996 and the 1997/98 funding agreement referred to the new
Policy. The Committee was told that, the performance monitoring
branch of the Ministry of Health – which was the branch responsible for
issuing the funding agreements – was not advised about the updated version
and so until 1996 the funding agreements referred to the 1991 Policy.
Although the funding agreements may have referred to the 1991 Policy,
from the evidence it appears that everyone understood that it was the
1993 updated version that applied. It would have been difficult to apply
the 1991 Policy after the health restructuring as that Policy
allocated responsibilities to the Department of Health and the area
health boards.
5.74 Clause 10.4 of the 1994/95 funding agreement read
:
"10.4 The RHA agrees to use its
reasonable endeavours to ensure –
10.4.4 All laboratories providing
laboratory services for cervical cytology and histology -
(b) are registered with TELARC (the
Testing Laboratory Registration Council of New Zealand) or an equivalent
quality assurance programme;" (emphasis added)
Clause s4.11.5 of the 1995/96 funding agreement and clause
s5.3.20 of the 1996/97 funding agreement also repeated this requirement.
However, in addition to these clauses, clause 10.3 of the 94/95 funding
agreement, clause 4.11.4 of the 95/96 funding agreement and clause 5.3.19
of the 96/97 funding agreement, provided that the National Cervical Screening
Programme, and the cervical screening services, were to be consistent,
inter alia, with the Government Policy for National Cervical Screening
(1991).
5.75 Ms Glackin accepted that the impact of clauses 10.3,
4.11.4 and 5.3.19 was to incorporate the 1991 Policy document as
a term of the funding agreement :
"Q It seems that the 1991 Policy
was actually incorporated into the funding agreements for 94/95?
A Yes, that is how it reads.
Q And if you would turn next to the
funding agreements 95/96 and go to page 112, … once again the 1991 policy
document is made a term of the funding agreement is it not?
A It is
Q Anyone reading the funding agreements
seeing that the 91 Policy was part of the funding agreement and
going to the 91 Policy para 4.1.3 would conclude that the Ministry
of Health would be responsible for confirming that the laboratories
met the requirements set out in 4.1.4?
A Yes.
Q And I understand your evidence is
that practically speaking, because the Ministry had no direct relationship
or influence over laboratories, it couldn’t discharge its responsibility
which it had under 4.1.3 of the Policy?
A The mechanism available to the Ministry
was through the Regional Health Authority funding agreement and as you
have pointed out that referred to the 91 Policy so yes it would
appear that was the case.
Q So it seems then that the Ministry
… knowingly allowed itself to be placed in a situation where it could
no longer responsibly carry out its responsibilities under 4.1.3.
A I believe that’s the case and I think
the problem associated with this is the one I refer to later in my brief,
which is a delay in the review of the Policy. At the time the
Policy was reviewed in 1993 it was envisaged that the review
would be completed in 1994, in fact it was not completed until 1996
which meant that the Policy stood as it had been originally worded.
5.76 This means that, although the updated 1993 Policy
intended the Ministry to be responsible for confirming that laboratories
carrying out cytology screening for the Programme met the accreditation
criteria in clause 4.1.4, this could not be done and, therefore, it was
not done. Ms Glackin accepted that there was nothing about clause 4.1.3
which was ambiguous about the responsibility it conferred on the Ministry.
She accepted that on reading the Policy document it appeared the
Ministry was responsible for carrying out clause 4.1.3.
"Q The Policy document says
the Ministry of Health will be responsible and is it fair to say on
reading 4.1.3 there is nothing ambiguous about that responsibility?
A There is nothing ambiguous about the
wording, the problem there was no apparent way in which that responsibility
could have been carried out."
Thus the 1993 updated Policy, produced
by the Ministry of Health, gave to the Ministry a role which it could
not fulfil. Hence, between 1993 and 1996 the intent of the Programme's
policy document did not reflect the reality of the Programme’s delivery.
5.77 Mr Mules gave evidence on the 1993 Policy
which suggested to the Committee that the Midland Regional Health
Authority’s understanding of its responsibilities to the Programme was
confused by the difference in the allocation of responsibility in the
Policy and the Funding Agreements. He said that the Midland Regional
Health Authority had not treated the laboratory component of the Programme
as a priority because it considered that it was the Ministry’s responsibility.
He described the 1993 Policy in this way:
"The responsibilities of the Ministry
of Health, the Regional Health Authorities, Public Health Commission,
Cervical Screening Advisory Committee and the Cytology Advisory Liaison
Committee are explained at page 8 of the 1993 Policy. The responsibility
of the Ministry of Health for introducing quality standards around the
reading of slides by pathologists was continued from the role of the
Department of Health in the 1991 Policy."
For the Regional Health Authorities
the specific laboratory component of the National Cervical Screening
Programme was a relatively low priority because we believed that the
Ministry was responsible for it. Our National Cervical Screening Programme
priorities were enrolment of women, improving access to screening and
treatment services, and ensuring collection and communication of data
from the local programme directly to the Ministry."
5.78 Later in his evidence Mr Mules confirmed his
views on the relationship between the funding agreements under which the
regional health authorities were operating and the Government Policy
for National Cervical Screening. He said :
"Between 1991 and 1996 the Department/Ministry
of Health was responsible for laboratory quality in respect of the National
Cervical Screening Programme, covering both definition of the criteria
for TELARC registration, and confirmation of which laboratories were
eligible to carry out National Cervical Screening Programme screening
work. The Department/Ministry also controlled the data from the National
Cervical Screening Programme Register that allowed comparative monitoring
and analysis of laboratory activity. Midland did not have such access."
5.79 When Mr Mules was asked whether or not, to
his knowledge, the Ministry was aware that the Midland Regional Health
Authority did not consider itself responsible for confirming whether or
not laboratories were TELARC accredited, his response was that it was
commonly understood amongst all parties that the Regional Health Authority
focus was on enrolment and colposcopy in respect of the Programme.
"Q I want to be clear then, you
can only give evidence of your experience of dealings with the Ministry
during this time, but from your dealings with the Ministry did you gain
the impression that the Ministry was aware Midland Regional Health Authority
believed because of the cervical screening policy in 4.1.2 and 4.1.4
that the laboratory component of the Programme was the responsibility
of the Ministry.
A If you are referring to those aspects
of the laboratory components as described in 4.1.2 to 4.1.5, yes. I
was never party to any discussions that would have made people think
otherwise. We were responsible in the context of moving from section
51 to laboratory contracts that would have introduced TELARC registration,
but that was in a generic sense.
Q As I read your evidence you are saying
the Regional Health Authority believed the Ministry was responsible
for the laboratory component of the screening Programme.
A Yes, as laid out in Policy
guidelines.
Q The point is if that was the understanding
of the Regional Health Authority, then whether or not there was any
monitoring and evaluation of the laboratory component of the Programme
would depend very much on whether the Ministry recognised that it was
responsible for that part of the Programme, wouldn’t it?
A Yes, it would depend on their interpretation
of the Cervical Screening Policy and the funding agreement.
Q What I am trying to find out from
your knowledge is whether or not the Ministry was aware of the Regional
Health Authority view.
A I’ve got no reason to believe that
they weren’t, and Jane Hudson was in frequent communication with the
national co-ordinator and as you’ve seen from the service requirement
definition Jane has carried forward the Policy into those documents.
I would have thought she would not have done that if she had a contrary
view.
Q The outcome would be if the Regional
Health Authority relying on the documentation believed the Ministry
was responsible for the laboratory component of the Programme in terms
of monitoring and evaluation, but if the Ministry itself believed that
it couldn’t carry that out as heard from Ms Glackin, it would really
mean no-one was doing the job, wouldn’t it?
A One can assume that.
5.80 Mr Lambie was responsible for the unit that prepared
and negotiated the funding agreements. He was asked to comment on Mr Mule’s
evidence about the regional health authorities’ understanding of their
obligations under the funding agreements. Mr Lambie accepted that there
was some ambiguity between for example clause 10.3 and 10.4 of the 94/95
funding agreement, however, he said that no regional health authority
had taken this up with the Ministry at the time the agreements were being
negotiated:
"Q …if you go to 10.3… it says
the regional health authority is to purchase cervical screening services
…this Programme and the cervical screening services are to be consistent
with … the government’s 1991 policy for national cervical screening.
And then under 10.4 it says the regional health authority is to use
reasonable endeavours to ensure a number of things including TELARC
accreditation...I think the difficulty is that in 10.3 there is the
reference to the purchasing of service being consistent with the government's’1991
Policy. So I think what Mr Mules was saying, well under the 1991
Policy certain responsibilities remained with the Ministry …in
terms of paras 4.1.2 to 4.1.4 of the Policy therefore you you’ve
got a tension within the funding agreements between, by incorporating
the 1991 Policy, that puts a responsibility on the Ministry,
which also para 10.4 appears to be putting on the regional health authorities.
What do you do when you’ve reached the end of the year and you say "
well who should have done what?"
A I accept that there is some potential
ambiguity. However, if that ambiguity had been recognised at the time
I think it would have been cleared up. I think that the key part of
this funding agreement was under 10.4.
Q And to the best of your knowledge
did the regional health authorities ever say to the Ministry, "well
we actually think the incorporation of the government’s 1991 Policy
…means the Ministry has certain obligations about laboratory services
and cytology as set out in that Policy agreement which conflict
with our funding agreement responsibilities?
A To the best of my knowledge that never
occurred.
5.81 There was clearly confusion between the two health
agencies in relation to their respective roles under the 1993 Policy.
Each agency appears to have had its own interpretation of the responsibilities
that the Policy and the funding agreements placed upon them, and
they each appear to have been totally unaware of their different interpretations.
Because of this neither said anything to the other about the confusion.
5.82 The presence of this confusion is confirmed for
the Committee by the review that the Ministry of Health carried out for
the Associate Minister of Health in April 1996. At the time it was considered
that accountability arrangements between the Ministry and the Regional
Health Authorities were contributing to problems with the Programme. Ms
Glackin informed the Committee that the official’s report dated 11 April
1996 identified three key problems for the Programme. One of these was
confusion between the Ministry and the Regional Health Authorities over
"accountabilities for the Programme". The Ministry appears to
have recognised at the time of the review that the Regional Health Authorities
"saw themselves as purchasing a series of individual components which
contributed to a programme owned by the Ministry rather than purchasing
an integral service for women."
5.83 The practical effect of this confusion is that it
seems from 1993 until the new Policy in 1996 the Ministry of Health
considered that it could not carry out the responsibilities the Policy
placed upon it in clause 4 and, therefore, it did not specifically
attempt to do so. But the Regional Health Authorities were not stepping
into the breach created by the Ministry’s inability to carry out its responsibilities
because as they saw it the Policy placed the responsibility for
the laboratory component of the Programme on the Ministry. The end result
of this confusion was that little, if anything, was done in terms of clause
4 of the Policy.
5.84 Certainly, in response to their contractual requirements
under the funding agreements with the Ministry, the Regional Health Authorities
were working towards requiring all laboratories to gain accreditation
for all of their services. Even then, the funding agreements only required
Regional Health Authorities to exert "reasonable endeavours"
to achieve accreditation. But, as Mr Mules acknowledged, this was different
from the specialised accreditation that the Policy contemplated
in clause 4.1.4 for laboratories reading cytology for the Programme. The
funding agreements did not reflect the content of the Policy; they
made no attempt to distinguish cervical cytology laboratory services from
other laboratory services by requiring cervical cytology to be read only
by TELARC accredited laboratories. No one was doing anything meaningful
to ensure that the criteria envisaged in clause 4.1.4 were actually being
developed, and once in place adhered to. There were many discussions with
various advisory groups about what should be done, but ultimately nothing
meaningful was done by the Ministry in relation to its role in clause
4 of the Policy.
5.85 There is another aspect to this confusion. On 24 November
1994 the Women’s Health Action group wrote to the Minister of Health regarding
a woman’s false-negative smear result and asked, inter alia, what structures
were in place to monitor laboratory quality and what information did the
Programme have about false negative rates in laboratories used by the
Programme, how were false negative rates monitored and how were they reduced
in laboratories where the rate was high. The Associate Minister responded
to the Women’s Health Action group on 30 March 1995 by advising them that:
"A variety of measures are in
place or are being developed to ensure that the quality of smear reading
is as high as possible. The 1995/96 Policy guidelines for regional
health authorities state that regional health authorities must ensure
that all laboratories providing cervical cytology and histology services
are registered with … TELARC or an equivalent programme. The National
Cervical Screening Programme anticipates that all laboratories will
have TELARC (or equivalent accreditation) by the end of 1996. Several
years ago the cytology advisory liaison committee made a number of
recommendations to TELARC relating to performance of cytology in medical
laboratories. These recommendations which were accepted by TELARC
at that time, have been recently revised and upgraded and a provisional
list of recommendations is currently being considered by TELARC.
As part of the TELARC registration
process laboratories are required to demonstrate both internal and
external quality assurance participation. While TELARC guidelines
do not specify which quality assurance procedure should be followed
in relation to external quality assurance the great majority of laboratories
are now registered with the Royal College of Pathologists of Australasia
Quality Assurance Programme in Cytology. With regard to internal quality
assurance there are a number of procedures which follow…"
Further on in the letter the Associate Minister said:
"With the reconfigured National
Cervical Screening Register and the comparison of histology and cytology
data, New Zealand will have potentially one of the strongest national
monitoring capabilities in the world. At this early stage, however,
I am advised that there is insufficient data to monitor particular
laboratories. I understand, however, that laboratories operate on
an informal process of review where false negatives are identified.
5.86 This letter illustrates the confusion which abounded
around the Programme at that time. Although the Associate Minister writes
that the 1995/96 Policy Guidelines For Regional Health Authorities
state that regional health authorities must ensure all laboratories
providing cervical cytology are registered with TELARC, the 1995/96
Guidelines do not say that. They were issued annually and outline
the Government’s priorities for health and disability services and the
services to be purchased by regional health authorities. The 1994/95
Guidelines said, in relation to cervical screening, that regional
health authorities:
"Are to ensure that their purchase
arrangements for laboratory services for cervical cytology and histology
reflect the requirement that all laboratories servicing the National
Cervical Screening Programme should be registered with TELARC."
(emphasis added)
The 1995/96 Guidelines (to which the Minister
had referred in her letter) said:
"Regional health authorities
are to ensure that their purchase arrangements for laboratory services
for cervical cytology and histology reflect the following requirements
that all laboratories serving the National Cervical Screening Programme
:
Forwarding cervical smear test results
(not accompanied by written notice of objection) to the National
Cervical Screening Register in the agreed format;
Provision of timely cervical smear
test results to smear takers."
Nothing else is said in the 1995/96 Guidelines about
accreditation of laboratories with TELARC or any other authority. When
the Associate Minister wrote in March 1995 that regional health authorities
must ensure all laboratories providing cervical cytology were registered
with TELARC, she was incorrect. Under the funding agreements of that time
they were obliged to use no more than their reasonable endeavours to ensure
laboratories were accredited. The Associate Minister had misunderstood
the true effect of the Programme’s Policy documents of 1991 and
1993, the Policy Guidelines To Regional Health Authorities and
the Funding Agreements in force at that time. Nowhere in any of those
documents, covering the period from 1993 to 1996, was there an obligation
specifying that all laboratories providing cervical cytology must be
registered with TELARC or an equivalent authority.
5.87 The Associate-Minster’s response shows that the
officials advising her did not realise the true effect of these documents.
This is confirmed by exhibit GRB/MOH/24 at page 36 which is a Ministry
action sheet. It records the officials’ advice to the Associate Minister
to enable her to respond to the Women’s Health Action Group. The action
sheet records that the "National Cervical Screening Programme is
the first programme which has ever made registration compulsory through
TELARC." This statement is plainly wrong. At the time the advice
was given (sometime between November 1994 and March 1995) TELARC accreditation
of laboratories reading cervical cytology for the Programme was not compulsory.
This appears to have been picked up in the Associate Minister’s letter
as that states that the Programme anticipates all laboratories will be
TELARC accredited by the end of 1996. This statement contradicts the earlier
(incorrect) statement that regional health authorities must ensure all
laboratories reading cervical cytology are TELARC accredited. All of this
demonstrates that neither the Associate Minister nor her officials had
a clear understanding of the Programme’s requirements of laboratories
reading cervical cytology.
5.88 The 26 July 1995 minutes of the Cervical Screening
Liaison Advisory Committee show that the Programme’s national co-ordinator
also had no clear understanding of the Programme’s requirements of laboratories.
She is recorded as asking the advisory committee for "clarification
on what the Programme would do if a laboratory had not improved with the
insistence of TELARC". The minute records that the advisory committee
"acknowledged such a situation would have to be investigated and
may require further action." This minute shows that the national
co-ordinator was unclear about what to do if a laboratory was not bringing
itself up to accreditation standard. The reality is that as at July 1995
there was nothing that the Programme could do. The Programme had no authority
over laboratories; there was no direct contractual relationship between
the Minister/Ministry of Health and laboratories. At that time laboratories
contracted with regional health authorities. The contracts did not require
laboratories to be accredited with TELARC or any other quality control
authority, therefore a laboratory did not need TELARC’s approval to perform
cervical cytology. If the Programme staff became concerned about the performance
of a laboratory the only legal means of addressing the problem would have
been to request the regional health authority which had contracted with
the laboratory, to exercise any contractual powers it may have had to
suspend the laboratory. The other possibility would have been for the
Minister of Health to issue a directive to the regional health authority
pursuant to his or her power in s.40 of the Health and Disability Services
Act. However, the exercise of a s.40 directive would have been an extreme
measure. In any event the effectiveness of either an informal request
or a s.40 directive would have depended on whether or not the regional
health authority had the contractual power to suspend a laboratory from
reading cervical cytology. What concerns the Committee is that the national
co-ordinator appears not to have understood the legal position, and she
did not know that the Programme could take no steps against a poorly performing
laboratory. She should have known that under the new health structure
the Programme’s staff had no power to take remedial action against a laboratory
that was either performing poorly or failing to meet TELARC’s requirements.
This is a further indication to the Committee of the lack of understanding
and confusion among those working in the Programme regarding the requirements
it placed on laboratories and how the Policy fitted with the Guidelines
to Regional Health Authorities and the funding agreements.
5.89 The confusion surrounding the accountability arrangements
and the impact this had on the delivery of the responsibilities in clause
4 of the Policy can be attributed to the poor design of the 1993
updated Policy. The design failed to ensure that the structure
of the Policy and the allocation of responsibilities under that
structure fitted well with the newly re-structured health sector and the
accountability arrangements between the Ministry and the Regional Health
Authorities (even though the 1993 Policy recorded that it had been
revised and updated to accurately reflect the structural changes to the
health sector). If the Ministry could not carry out its responsibilities
in clause 4.1.3 these responsibilities should have been placed with an
agency in the new health structure, which was well placed to carry them
out.
5.90 The Policies of 1991 and 1993 were operative
throughout the time that Dr Bottrill was practising at Gisborne Laboratories.
The inclusion in both Policies of an intention that quality control
be assured by accreditation with TELARC or another similar authority shows
that the Department and the Ministry accepted the importance of accreditation
and saw that it was needed.
5.91 However, both Policies had no intrinsic means
of compelling accreditation. Nor were they designed around extrinsic means
of compelling accreditation. Prior to 1993 the Ministry believed it was
powerless to enforce accreditation. Dr Boyd told the Committee that, once
the National Cervical Screening Programme was in operation, the Department
had sought advice on making laboratory accreditation with TELARC or a
similar authority a condition of payment under the Social Security (Laboratory
Diagnostic Services) Regulations from one of its in-house solicitors.
The advice the Department received was that it was doubtful as to whether
the regulations permitted this. After 1993 the power the Ministry had
through the funding agreements with the regional authorities was not exercised
in a way which would have secured compulsory accreditation. This was implicitly
accepted by Dr Lambie, the Deputy Director-General, Corporate in the Ministry
of Health. Dr Lambie’s evidence was that many of the service obligations
in the funding agreements between the Ministry and the regional health
authorities were qualified by the words "reasonable endeavours."
At the time the Ministry had three types of service obligation which it
imposed on regional health authorities through the funding agreements.
These were: mandatory obligations; obligations to use "best endeavours
to ensure" something was done and obligations to use "reasonable
endeavours to ensure" something was done. Of the three types of obligation,
the obligation to use reasonable endeavours was the weakest. The end result
was that the National Cervical Screening Programme was powerless to
ensure that the cytology of the women, whom the Programme was
designed to benefit, was competently read.
5.92 Mr Lambie also accepted that in terms of an attempt
to measure the progress towards TELARC accreditation, that would be more
easily achieved if there were a finite time frame in place. And that once
the finite period of two years in paragraph 4.1.2 was removed from that
paragraph in the 1993 updated version of the Policy, progress towards
accreditation became more difficult:
"Q For example, under the 91
policy when you got to 93, if you could see that laboratories were
still unaccredited at that time it would be very clear to you that
the intent in the 91 policy had been completely achieved.
A Absolutely.
Q But when you move to a circumstance
where there is no finite period and the move to accreditation is dependent
on a reasonable period of time, it then requires a subjective decision
on what is a reasonable period of time in order to be able to determine
whether the move towards accreditation is proceeding slowly or quickly
or somewhere in between, is that right?
A That’s right.
Q In that sense, then, in wanting
to assess whether or not the move towards accreditation is happening
in a manner with which you are happy, it is much more difficult to
do that without a finite timeframe, isn’t it?
A I absolutely agree.
Q And it would also be more difficult
to be critical of laboratories that hadn’t become accredited if you
hadn’t imposed a finite timeframe by which they should be.
A Yes."
5.93 The Ministerial Review Committee of November 1989
had advised the Minister of Health that the success of a cervical screening
programme turned on all aspects being developed simultaneously as each
was an integral part of achieving success. Unfortunately the National
Cervical Screening Programme was not planned in this way. Compulsory quality
control and laboratory accreditation was seen by everyone from the Programme’s
outset as important and necessary. Yet it did not become an integral part
of the programme until some time after Dr Bottrill’s retirement.
5.94 Section 12.2.2 of the Policy Statement Of
The Government Policy For National Cervical Screening Expert Group had
recommended that all laboratories reading cervical cytology be accredited
with TELARC or an equivalent authority by 1993. Section 12.2.3 had recommended
that the Department of Health should be responsible for confirming that
laboratories reading cervical cytology were TELARC-accredited and that
without this confirmation a laboratory could not be paid. Had this entire
recommendation been placed in the Government National Cervical Screening
Policy 1991 it would have ensured that all laboratories were accredited
by 1993.
5.95 Ms Grew, who was the National Co-ordinator
during the time when the 1991 Policy was being developed, told
the Committee that she had received oral legal advice that it was not
possible to tag payment to laboratories in that way. However, the Department
promoted legislation in 1993 to allow for an opt-off register and the
recording of histology results. It seems to the Committee that if the
Department believed that it did not have the legal authority to require
TELARC accreditation as a condition of payment for laboratories and it
considered that laboratories should be TELARC-accredited it should have
promoted legislation to achieve this end. Apart from evidence that the
Department was informed by its legal advisers that it had no power to
make TELARC accreditation compulsory the Committee has seen no evidence
of the Department taking any further steps to attempt to procure for the
Minister or the appropriate departmental officer the necessary authority
to permit TELARC accreditation to be made compulsory.
5.96 The Committee did not receive a satisfactory explanation
for why nothing was done to ensure that the design of the 1991 Policy
mandated TELARC accreditation by a specific date. The explanation the
Committee received suggested that at the relevant times the national co-ordinators
were overly reliant on the advisory groups and did not act to ensure that
the design of the Policy and its implementation carried out the
intent, which it seems everyone had, for laboratories to be accredited.
Certainly, in the Committee’s view, making TELARC accreditation a condition
of payment would have forced those laboratories that wanted to continue
reading cervical cytology to become accredited. These issues were raised
with a panel of Ministry officials who gave evidence at the final day
of the public hearings :
"Q At the moment we’re talking
about 1990 and there is a report that the expert group has prepared
in 1990 saying that reading smear tests by laboratories payment should
be tagged to TELARC accreditation. Now we haven’t seen anything set
out dealing with what the Ministry’s response was at the time. What
we have seen is a screening policy statement of 1991 which picks up
some of what is in paras 12.2.2 to 12.2.4,but it certainly omits the
requirement that the laboratory benefit payment be tagged with a TELARC
accreditation requirement. Can you comment on that?
A - Ms Grew In the first six months
of my job I have to say that dealing with this particular aspect of
the Policy was not attainable in the first six months.
Q What about after?
A – Ms Grew Even afterwards it was
not possible. I did obtain oral advice which I asked legal to put
in writing in 1992, but it was consistent that I had to change the
law. I considered the other requests from the expert group which were
that it was extremely important to ensure that the Register was not
opt-on as it was; that I should change that, and also that it was
vital for histology to be linked with cytology register. Those were
the two priorities …
Q To come back … to this other point
about TELARC accreditation, it just goes beyond the period you were
there, so anyone else can answer too. Certainly legislation was amended
in 1993 with s.74A and it could have been possible, if primary legislation
was needed, to amend legislation at that time to enable a regulatory
requirement for laboratories reading cytology to be TELARC accredited
to be put in place, couldn’t it?
A – Ms Grew It could have. I wouldn’t
like to underestimate the huge task involved in simply getting the
consultation around the opt-off register and also getting laboratories
to agree to use the Bethesda coding system to enable the same reporting
and to also get the laboratories to agree to send the opt-on women’s
cytology results to the registers around the country. That in itself
was a big task for the laboratories to adjust to, and I would suggest
to you that getting agreement to be TELARC accredited on top of all
of that, which I’m sure you’ve heard in evidence, is expensive, would
have been a huge ask for the laboratories and the consultation itself
would have been quite significant.
Q Are you saying that you were concerned
that the laboratories would refuse to do cytology work if a regulation
had been passed requiring TELARC accreditation?
A – Ms Grew No I’m not saying that.
I’m saying that we required a great deal of co-operation from the
laboratories and they were very co-operative in terms of all agreeing
to use the Bethesda coding system, or agreeing to send cytology smear
results on disk to the registers. I also have to say that Clint Teague
consistently assured me that the laboratories were all moving towards
TELARC accreditation. I did raise it as a concern, and it’s minuted
further down the track in the Cervical Screening Advisory Committee
minutes.
Q But it’s clear that as at 1993 when
the screening Policy was redone to accommodate the Ministry
rather than the Department of Health, the requirement in 4.1.2 of
the Policy that TELARC accreditation be achieved by 1993 because
the 1991 Policy said within two years had not occurred, and
the Ministry’s response at that time was to leave the matter on the
basis that TELARC accreditation would be achieved within a reasonable
period. Why did the Ministry chose to do that when it wrote the 1993
Policy?
A – Ms Dahl I’ll answer that question.
The 1993 update of the 91 Policy occurred in my time. I started
in January and we started to update that soon after. The reason for
updating that was to reflect the health reforms, to reflect the changes
in the health structure. We did not review the Policy, we updated
the Policy. The removal of the two year clause, I can’t exactly
remember how it occurred, but it was not to make it more lukewarm
or to reduce its impact. It was based on advice that laboratories
were working towards TELARC accreditation. Many of them were already
there, and we didn’t need to put something in there that said two
years, there were other ways to make that occur. Meanwhile, we had
also started to review with the Cytology Advisory Liaison Committee
the TELARC criteria for accreditation, and there was no expectation
at the time that that was going to take as long as it took. There
was an expectation that that would have been finished within several
months.
Q At the time, TELARC was accrediting
laboratories wasn’t it?
A – Ms Dahl Yes it was.
Q It had its own standards which it
used for the purposes of accrediting medical laboratories, didn’t
it?
A It did. We did have some meetings
with TELARC in the early parts of 1993 to discuss what they were accrediting
against, and the adequacy of those criteria, and there was agreement
with the CALC Committee that they needed to be reviewed, that in the
meanwhile there were criteria but they did require review.
Q My understanding was that there
are medical laboratories that are accredited, and then you accredit
different departments differently. You can be accredited for one department
and not another, and that when it came to cytology, it was really
there was a need to look at whether there ought to be other criteria
over and above what was already in existence. Is that right?
A – Ms Dahl That’s correct.
Q And my understanding is that the
Policy itself as a result of the expert group’s meeting had
determined some criteria which it thought should be in the TELARC
accreditation, which would include standards set such as how many
minimum smears per year were read, employment of adequate numbers
of suitably qualified staff, maximum workload for each cytoscreener,
adequate in-service education, satisfactory participation in internal
/ external quality assurance procedures and co-operation in providing
cytology reports to the cytology register. Now they were criteria
that the Department of Health under the 91 Policy and the Ministry
of Health under the 93 Policy saw as being important for the
purposes of the Programme, and those criteria could be imposed either
through TELARC accreditation or some other means really if the Ministry
had wanted to ensure that the criteria was in place. Isn’t that right?
A I would have been unsure what other
means there would have been. My advice came from the CALC committee,
I was not a technical expert on laboratories, and my understanding
from that Committee was that laboratories were moving towards accreditation,
everything was okay and that they would work on reviewing the criteria
for the TELARC accreditation and that was the advice that I worked
on in the period that I was there.
Q Another possibility would have been
for the Ministry as part of the Programme to have drawn up its own
standards and to have said that those laboratories that wanted to
do cytology screening for the Programme must adhere to those standards.
A – Ms Dahl That’s correct ma’am,
and in many instances that type of process occurs in various Government
departments and it’s a very appropriate process. At the time that
we’re talking about that was not the process that was working within
the Department of Health, Ministry of Health. We were very reliant
on expert groups and they were the groups that were advising us and
we were following through on that process. Hindsight may prove that
may not have been the best way.
5.97 Had the Programme been able to ensure that all laboratories
reading cytology were accredited that would have stopped the cytology
practices that were carried out at Gisborne Laboratories between 1990
to March 1996. The Committee has already said that it considers that these
practices are likely to have led to unacceptable under-reporting. Had
they been prevented then the under-reporting would have been avoided.
In the Committee’s view a programme with a well-designed policy that was
well implemented would have had in place measures to ensure laboratories
practised quality control and were accredited. And the persons responsible
for the Programme would have applied these measures if a laboratory failed
to comply. For this reason the Committee considers that the poor design
and implementation of the Programme’s policy in relation to laboratories
is a factor that is likely to have led to the unacceptable reporting in
the Gisborne region.
Failure To Ensure The National Cervical Screening
Register Functioned Optimally
5.98 During the time Dr Bottrill was in practice the
National Cervical Screening Register had two major flaws:
(i) When the National Cervical Screening Programme
began instead of a central register there were 14 stand-alone registers,
each of which was located in an area health board region. The 14
registers were unable to correlate a patient’s histology results
with her cytology results. Nor were the registers able to inter-link
with each other in relation to a patient’s cytology results;
(ii) The registers were initially "opt-on"
registers. This meant that women had to request that their cytology
results be recorded on the registers. Many were either not given
the choice or opted not to have their results registered. The number
of women whose results were recorded on the registers was not sufficient
to enable statistically meaningful information to be derived from
the registers.
The Committee will address each of these flaws below.
No Centralised Register Capable Of Correlating Histology
With Cytology
5.99 A centralised cytology register which linked
histology with cytology results was considered, by all the authorities
on cervical screening to which the Committee was referred, to be pivotal
to a successful screening programme and an essential management tool
for proper quality control. The National Cervical Screening Programme
did not have such a register until 1997.
5.100 It appears that the original plan for the Programme’s
register was to have a nationally computerised register which was
to be managed locally by area health boards. This is recorded in The
Report of the Ministerial Review Committee of November 1989.
This design is consistent with the recommendation made in the Cartwright
Report for a centralised register based on a "regionalised"
network. The Review Committee reported its support for the view that
a population-based programme required a national computer based register.
The Review Committee said that it was essential to extend the cytology
register to include histology information so as to enable cytology
and histology results for women to be correlated. The purpose of this
recommendation was to allow an assessment of the overall effectiveness
of the Programme to be conducted, and to provide a means of assessing
the quality and uniformity of smear reading across the country.
5.101 On 30 May 1990 the National Cervical Screening
Programme Expert Group reported to the Minister. The report recommended
the establishment of three nationally based and inter-linked registers.
A national cytology register with the cervical smear test results
of individually identified women; a population register which would
eventually contain the names of all women in the population; and a
histology register which contained the results of biopsies to determine
the rates of pre-cancerous abnormalities and cervical cancer. The
Expert Group said that each of the three registers was integral to
the Programme and that the failure of any one of them would jeopardise
the Programme. Subsequently in August 1990 the Expert Group produced
the Policy Statement Of The National Cervical Screening Programme
Expert Group. In this document the Expert Group said that:
" …the expansion of the cytology
registers to include relevant histology was an urgent priority,
not only to ensure that women with abnormal smears are being properly
followed up but also to evaluate the quality of smear reading
in laboratories." (emphasis added)
5.102 Judith Straton in her review of the Programme
in 1990 emphasised the importance of a register which linked cytology
with histology results:
" …the provision of histology
to the Register is essential for the correlation of cytology and
histology reports, which provide an important measure of the
quality of the screening."(emphasis added)
5.103 It appears from reading the Straton Report
that Judith Straton was also aware of the decision to locate a cervical
screening register with each area health board. Like the Ministerial
Review Committee she too favoured having the registers in each area
health board linked to a central register. Also in 1990, the National
Cervical Screening Programme Expert Group recommended that the Programme
be linked to the Cancer Registry to provide correlation of smear reading
results with proven cancer, even though the histology specimen may
have been reported by another laboratory at a later date.
5.104 The Cancer Screening 1991 Cervical Screening
Recommendations A Working Group Report described a national
register as: "the essential management tool to allow a proper
valuation of all the components of the screening process". It
also said that a register should, "include relevant histology
results to allow co-relation and evaluation of cytology findings."
5.105 The World Health Cervical Cancer Screening
Programme Managerial Guidelines, issued in 1992, recommended:
"…an efficient monitoring
requires a system of linked records. A population register (or
available substitute) allows periodic call back for re-screening
at appropriate intervals. The cytology register when linked with
a cancer register (which should be ad hoc and specific to cervical
cancer) permits women with cytological abnormalities to be recalled
for repeat screening diagnosis and therapy. Evaluation of the
programme can then be carried out with regard to the assessment
of :
Management of women with positive
smears;
False negative smears;
Cancers which are detected during
the interval between consecutive screens;
Groups missed in the target
population.
5.106 The benefits of correlating histology with
cytology results were confirmed for the Committee by Dr Boyd.
He told the Committee that correlation of histology and cytology results
can be considered as an external and internal quality assurance activity.
He said that as an external check on a laboratory’s performance the
Register can provide statistics to show the proportion of women having
colposcopy whose histology results confirm the result of a previous
smear reading; and those whose histology results do not confirm previous
smear readings. Either way the histology results provide helpful information
when it comes to assessing laboratory performance in smear reading.
If the histology results confirm the cytology results, that confirms
the laboratory’s accuracy in reading smear tests. If the histology
results do not confirm the cytology results that would mean either
the cytology results were false or the biopsy did not sample the lesion
detected by the cytology. It could also be due to the misreading/misreporting
of the histology. The proportion of false positives and false negatives
that a laboratory produces can indicate whether or not the laboratory’s
performance is acceptable, and consequently whether or not unacceptable
under-reporting is occurring.
5.107 Dr Boyd described the Register’s usefulness
as an internal quality control to the Committee in the following way:
" … the correlating of cervical
cytology reports generated within the laboratory with the histology
reports obtained following colposcopy and the reports of cancer
incidence from the cancer registry provides an opportunity to
re-examine the previous slides with a higher index of suspicion.
The laboratories develop their own protocols for this look-back.
The look back should not be restricted to the most recent slide.
In one laboratory I visited an arbitrary figure of five years
has been selected, so that all previous slides for that woman
over that period are re-examined."
Professor Skegg described the correlation of cytology
results with histology results as being of "fundamental importance"
and he said it was "inexcusable that so many years elapsed before
it was done".
5.108 During the early stages of the Programme’s
development, all the advice to the Minister and the Department of
Health from the various advisory groups, consultants and the available
overseas literature favoured a centralised register which linked histology
with cytology results. The only variation in this advice was between
the view that there should be one national register or alternatively
a series of regional registers which inter-linked with a central computer.
Nevertheless, when the National Cervical Screening Programme began
it was not designed around a centralised register. Instead there were
14 stand-alone registers each associated with an area health board.
There was no linkage between these registers, and since the histology
results were not recorded, the registers did not allow histology results
to be correlated with cytology results. This arrangement caused problems
and prevented the Register from functioning optimally. One of these
problems was that the usual capability of a screening register as
a tool for quality assurance was seriously compromised. The Register
could not be used as a source of information to show if there was
unacceptable under-reporting of smear test results.
5.109 The 14 stand-alone registers were installed
in all 14 area health board regions between December 1990 and September
1991, and they were all fully operational by early 1992. The Department
of Health supplied each area health board with the same software and
hardware, however, the computer systems were not linked electronically.
This meant that all transfers of information between local sites were
done by paper. This state of affairs continued until the registers
were finally reconfigured into a central register, which was completed
in 1997.
5.110 Ms Glackin told the Committee that not
having a centralised system: "Did create a problem and was very
time consuming when women moved to a different region." She said
that the fourteen separate registers led to difficulties with tracking
women who moved, and that this compromised the Register’s recall functions.
The Registers could not verify personal data electronically between
them. Women who may have been enrolled in one region re-enrolled in
another region. This led to duplication in enrolments. Until the 14
stand-alone registers were combined, each register could only give
the smear histories of women who were enrolled in the region where
that register was located. Only since 1997 has data for the whole
of New Zealand been accessible from any regional co-ordination
site. The software programme for the 14 registers did not allow histology
to be linked with cytology. But, even if the software had allowed
it, because there was no centralised system which could track women
when they moved to other area health board regions the histology results
still could not have been effectively linked with the cytology results.
5.111 The Committee learnt from Ms Sandra Matcham,
who is the National Register Co-ordinator for the Programme, that
once the 14 registers got underway, there were difficulties with some
regional sites. She said that 11 of the smaller regional sites had
sufficient capacity for their processing requirements, but that the
Wellington and Canterbury sites began to show signs that their systems
could not cope with the volume of work and by 1994 the Auckland site
had reached the point where processing the information had become
difficult for the staff, and they were progressively getting behind
with the work. This pressure helped to delay the progress of the re-configuration
of the registers. It is also another example of the difficulty created
by having 14 stand-alone registers.
5.112 The Committee heard from Ms Gillian Grew who
was the first National Co-ordinator of the National Cervical Screening
Programme from June 1990 to July 1992, and from Ms Susan Dahl,
who was the National Co-ordinator from January 1993 to September 1994
about the difficulties the 14 registers caused them. Ms Grew
told the Committee that not having a single database was one of the
difficulties the Department encountered when it came to prepare the
first statistical report for the Programme. Ms Dahl, who was
the co-ordinator at the time the second statistical report was prepared
said that it was :
"Very difficult to do the
second statistical report and that related to the fact that we
did have 14 registers at the time.".
5.113 She told the Committee that the Ministry had
to create programmes to get the information downloaded from the 14
sites and then compile the information in Wellington. She said that
once the Register was reconfigured the Ministry believed that data
would be more readily available, and therefore it would be easier
to prepare statistical reports. Since its inception the Programme
has prepared only three general statistical reports and one statistical
report on for Maori women. The Committee also learnt from Ms Grew
that quite early on in the Programme area health boards began to tinker
with the registers’ software programmes, and this had the effect of
"confounding" the national statistics. Ms Grew’s comments
on the impact of the 14 standalone registers on the Programme were
:
‘In the first place I couldn’t
see why New Zealand needed 14 registers and it became very apparent
that that was highly undesirable given, you know, the fact that
women moved around the country. Although there were arrangements
for electronic transfer on disk it seemed incredibly inefficient
to do it that way, and I do think that having 14 different sites
dealing with the software there were high risks, and I know from
the register people now that they had to clean up the data considerably
when they reconfigured into one register."
The Committee also learnt from Ms Grew that
until the Register became an opt-off Register which was capable of
correlating histology results with cytology results she was unable
to quantitatively monitor the quality of laboratory performance. She
said that was why she worked to get "opt-off" registers
which recorded and correlated histology with cytology.
5.114 The first support the Committee was able to
find in the evidence for regionally based registers was in a report
dated 21 November 1988 by Azimuth Systems Limited for the Department
of Health. The Committee understands that Azimuth Systems Limited
was a computer consulting company. The report was titled Proposal
for a National Co-ordinated New Zealand Cervical Screening Programme.
The Azimuth report referred to the planned establishment of area health
boards and recorded that as a result the Department of Health would
no longer be directly involved in the delivery of healthcare through
its regional health development units. It then reviewed implementation
options for a screening programme. These were: a single national system
with remote access provided for each area health board or a separate
system in each area health board region with linkages through a national
master patient index. It described the national system as having all
data and processing carried out using a single facility with each
area health board having remote terminals and printers. Data was to
be partitioned so that each area health board only had access to and
control of its own data. The advantages of this system were said to
be: simplification of day to day operations, provision of a uniform
system throughout the country, simplification of data transfers on
women who move between areas, simplification of the interface to a
national patient index. The disadvantages of a single national system
were said to be a need for extensive co-ordination between area health
boards, providers and "the national level", separation of
both physical and control aspects of the computer system from the
cervical screening programme users and the impact on strategic data
processing options and initiatives of individual boards since it would
require them to use equipment and facilities which may not be suitable
to them. The Azimuth report then described the second option of having
separate systems for each area health board. This option was said
to require a means of accessing a national patient index to maintain
name and address information and to identify women who have not yet
had cervical smears. The report also noted that a regionally based
system must allow for information to be exchanged with other regional
systems when women move between areas. The advantages of this option
were described as: having a minimal impact on area health boards’
autonomy in selecting hardware and software for local information
processing, providing area health board centres with autonomous control
over the operation of their service, allowing integration with other
systems operated by area health boards, being more responsive to local
needs without impacting on the national screening programme. The disadvantages
were described as being: the need for a national co-ordinating function
to set the minimum requirements and the protocols for information
exchange and to monitor the national register. Secondly, full implementation
of the national programme was dependent on the slowest implementation
by an area health board. After having reviewed these two options the
report concluded by recommending a separate registration system for
each area health board. The reason for preferring this option was
said to be the present policy intent to decentralise health care management:
" Given the present strategic
direction of decentralising health care management responsibility
to area health boards then a separate system for each AHB
[area health board] Centre is proposed. Each AHB Centre will
have access to a nationally maintained patient index and an
investigation of the existing National Master Patient Index
system should be undertaken to determine if it is suitable
for this role."
There is no reference in the Azimuth Report to any
authoritative literature on screening programmes that would support
the establishment of 14 separate registers. The recommendation appears
to emanate from policy considerations arising from the decentralisation
of health services rather than to have been driven by sound principles
relating to the organisation of screening programmes.
5.115 Another reason supporting regionally based
registers appears in Judith Straton’s Report. She describes the presence
of a widespread suspicion about the Register among women and health
professionals. She says that this suspicion was partly related to
the perception that the Register was primarily based in Wellington.
She says the suspicion may have lessened if the registers were promoted
as regional area health board registers with only non-identifying
data going to Wellington. She also said that the notion of the register
for national audit had been over-emphasised and that the register
"needed to be brought down to the level of the individual woman
with an indication of what the benefits are to her." She continued
in this vein by stating that:
" Giving women too many details
about the workings of the Register, while laudable, is quite likely
to be counter-productive, as women may be intimidated by it. This
applies particularly to women who are most at risk, who tend to
be older and less well educated, and may have good reason to be
suspicious of government bureaucracy."
The Committee considers that if reasons such as these
influenced the Minister of Health in the choice of stand-alone registers
it is a matter of regret. There was good reason for either a regionally
based but inter-linked centralised register or for one register to
hold all the information. There is no good reason to support having
14 stand-alone registers which were incapable of sharing information.
All such registers could do was to record a woman’s smear tests during
the time she resided in a register’s locality and act as reminders
to her when the time had come for another smear. They could not reliably
be used as a quality assurance tool to allow monitoring and auditing
of the programme, (and included within that is laboratory performance),
or as a source of epidemiological information to help reduce the incidence
of cervical cancer because there could never be any certainty that
the information recorded on a register about a woman gave a complete
record of her cervical history. In the Committee’s view it would be
a very short-sighted woman who did not appreciate the benefits to
herself of these wider measures. It is of concern to the Committee
that in 1990 an assumed timidity and ignorance on the part of women
could be given as a reason not to inform them fully about the Programme.
5.116 A further reason for regional registers appeared
in the evidence of Ms Sandra Coney. She informed the Committee that
in the beginning in some regional areas people were concerned about
information going outside their region and they felt they would have
more control over it if it were recorded on a register based in their
region. This is similar to the view expressed in the Straton Report.
However, it is not a view which justifies running 14 stand-alone registers.
The inefficiencies, which result from this structure, clearly outweigh
any concerns about misuse of information. These concerns could have
been accommodated in other ways. Furthermore it is difficult to see
what is to be gained in storing information regionally; that in itself
does not guarantee the protection of the information’s confidentiality.
The type of protections that do keep information confidential can
work just as well on a national basis as they can on a regional basis.
5.117 Against these reasons are the sound epidemiological
reasons for having a central register which recorded the smear histories
of women throughout the country and which allowed cytology results
to be correlated with histology results. The Ministerial Review
Report of 1989 emphasised the importance of ensuring that the
links required to build the regional system developed by Azimuth into
a national system needed to be put in place. The Expert Group’s report
to the Minister on 30 May 1990 emphasised the need for a national
based cytology register. The Policy Statement Of The National Cervical
Screening Programme Expert Group dated August 1990 recommended
a regional system of cytology registers which were linked to a central
register.
5.118 Ms Glackin told the Committee that a decision
was made early in the development of the Programme that there would
be 14 stand-alone register sites. Even though the Azimuth Report had
supported having separate regional registers it is difficult to see
why this advice was followed. The limitations of 14 stand-alone registers
should have been obvious from the outset. The Straton Report had at
least favoured registers in each area health board region which were
linked to a central register.
5.119 Ms Matcham told the Committee that it
would have been technically possible to have net-worked the regional
computer data bases to a central site between 1990 and 1991, as a
register was set up in each area health board’s region, but at significant
cost. She said that a much larger central computer would have been
necessary and that telecommunication lines 10 years ago were more
expensive than they are today.
5.120 No-one from the Ministry gave the Committee
an explanation as to why, from the outset, a single computer located
in one site could not have been used to hold the cytology results
for all women whose results were being recorded. The relevant female
population for screening in New Zealand is not large. It could easily
all have been accommodated on one centralised register. The expense
Ms Matcham spoke of was for the type of system now in place where
the 14 regional computer sites are networked to a central site. While
this may have been expensive in the early nineteen nineties it does
not follow that at the outset a single computer based in one locality
would have been more expensive than the system of 14 separate computers
which was adopted. If a centralised system of regionally inter-linked
computers was too expensive, a single computer with systems in place
to ensure that laboratories throughout the country forwarded their
results to the computer could have worked. Although a larger computer
would have been needed, it would be surprising if the cost of one
computer to hold all the information would have been more costly than
a centralised system of regionally inter-linked computers. It may
also have been less costly, once all the duplication and consequential
inefficiencies were taken into account, than the 14 stand-alone computers
of a smaller size. The Committee has learnt that the laboratories
forward information on floppy disk to the regional co-ordination site.
The information is then read into the database and validated. Rather
than laboratories sending information by floppy disk to regional co-ordination
sites, it is difficult to see why from the outset they could not have
sent the information to a single computer. For those laboratories
unable to send the information electronically, they could have sent
it in paper form.
5.121 With the change to a decentralised health system
which used area health boards to deliver health services, the Minister
may have considered that a centralised system of inter-linked regional
registers was too expensive at that time and that a single nationally-based
register, for which the Department was responsible, was at variance
with the move towards a more regionally based health system. While
the concern for expense and the desire to adhere consistently to an
adopted philosophy for health delivery is understandable, it should
not have been allowed to affect detrimentally the design and implementation
of the National Cervical Screening Programme. The design of the Register
was fundamental to the success of the Programme. Professor Skegg had
written of this in his article in the New Zealand Medical Journal
of October 1989 titled How Not To Organise A Screening Programme.
He wrote:
"Schemes based on inadequate
registers are doomed to fail."
Although Professor Skegg was writing primarily about
the decision to have opt-on registers, it is clear to the Committee
that he did not support regionally based separate registers as he
referred with approval to the notion of a comprehensive population
based register. The Committee considers that Professor Skegg’s comment
on the impact of inadequate registers on screening programmes can
be read as being of general application to any material inadequacy.
When his comments are read with the comments from the Ministerial
Review Committee and the Expert Group supporting a national cytology
register this should have signalled a warning against having 14 stand-alone
registers.
5.122 There was sufficient authoritative material
at that time about the importance of a well-designed register. None
of the authoritative material the Committee has seen recommends having
a discrete series of registers that cannot communicate with each other.
Nor was the Ministry able to point the Committee to any material that
would support the idea of having fourteen stand-alone registers in
a country the size of New Zealand. Whatever may have prompted
the setting up of 14 stand-alone registers, there is nothing in any
material that the Committee has seen to suggest that it was a sound
way to set up a cervical screening programme’s register. If the decision
to have 14 stand-alone registers was influenced by a concern to ensure
that the register fitted in with the new decentralised heath structure
it is most unfortunate. The effectiveness of the register should not
have been compromised by considerations of that kind.
5.123 By February 1993 the Minister and the Ministry
of Health had accepted that the 14 standalone registers needed to
be inter-linked nationally. In February 1993 the Associate Minister
approved the release of a discussion paper dealing with future reconfiguration
of the Registers. By April 1993 consultation over the options for
reconfiguration was completed with the majority support being for
a national register with remote access. Final approval for the reconfiguration
was given on 12 January 1994. Final approval to start tenders
to allow the reconfiguration to be implemented was given in late 1995.
The reconfiguration started in May 1996 and was completed in February
1997. Since 1997 there has been one centralised stand-alone database
with regional access from 14 sites.
5.124 Although the need to link histology with cytology
was recognised relatively early on in the Programme’s implementation
this was not achieved until late 1996. Without a national register,
which linked histology with cytology, it was impossible to gain sufficient
information to evaluate laboratory performance. The benefit of correlating
histology and cytology results can be seen from what happens now.
At present a laboratory can request from the Register reports which
give details of the histology reports for all women for whom the laboratory
in question has read cytology results in the previous five years.
Where there has been a negative smear reported within five years prior
to a high-grade histology result, that information is highlighted
automatically by the Register when generating the report. Thus the
type of information which can immediately bring to a laboratory’s
attention a suspect cervical history is readily accessible. This allows
a laboratory to check whether or not earlier negative smear results
are correct or result from under-reporting. This type of "look
back" investigation using the Register has two benefits : it
can assist laboratories to discover errors in their reporting; and
it can be used by Programme staff to detect laboratory errors. It
has only been available since February 1998.
5.125 If, from the outset, the Register had been
configured as a single national register with correlated histology
results with cytology results, an effective tool to monitor laboratory
performance would have been available to pick up Dr Bottrill’s under-reporting.
Once one of his patient’s had a biopsy with positive results the computer
could have generated a report showing the patient’s cervical smear
history. Certainly before any use could be made of this information
someone would have to request it. However, if Dr Bottrill had
known this information was readily available he may have done so.
Equally, the Programme could have employed someone to request routinely
the smear histories for women with positive histology with a view
to checking the results of their earlier smear tests as part of a
regular monitoring exercise.
5.126 The Committee has already concluded that the
failure at Gisborne Laboratories to have an organised programme which
correlated a patient’s cytology results with her histology results
and which looked back on her previous smear history was a factor in
the unacceptable under-reporting at that laboratory. The Committee
considered that had Gisborne Laboratories carried out this procedure
it may have alerted Dr Bottrill to his very low false positive
rate and so caused him to realise that he was being overly critical
and " setting the bar too high" when reading smear tests.
This in turn should have alerted him to the probability that he was
under-reporting too many smear tests.
5.127 A centralised screening register, which was
designed to correlate a patient’s cytology results with her histology
results, would have been an effective substitute for, if not an improvement
on, a laboratory organised programme to correlate cytology with histology.
If the National Cervical Screening Register had been in this form
during the time Dr Bottrill was in practice it would have been a source
of information to alert him to signs that he was under-reporting smear
tests. For this reason the Committee considers that the inability
of the Register to provide Gisborne Laboratories with access to this
information during the time that Dr Bottrill was in practice is a
factor that is likely to have led to unacceptable under-reporting.
"Opt-on" Registers
5.128 When the Programme began it was based on an
opt-on register. Women had to actively exercise a choice to go onto
the Register. The result was that enrolment was not as high as the
Department would have liked, and the Register was insufficient to
be able to derive any statistically meaningful information. Studies
in New Zealand and overseas showed that an opt-on register was
likely to recruit only 30-40% of women having a smear, and that with
such low enrolments there was risk that there would be too few women
enrolled on the Register for the Programme to meet its objectives
of increasing coverage and reducing mortality and the incidence of
cervical cancer.
5.129 In October 1989 Professor Skegg published an
article in the New Zealand Medical Journal titled How Not To Organise
A Screening Programme. In this article Professor Skegg was very
critical of the use of opt-on registers. He wrote:
"There is abundant evidence
from other countries that it is possible to spend vast sums on
cervical screening without achieving much. We cannot afford to
repeat their mistakes. Despite the lack of details one aspect
of the New Zealand scheme sounds particularly ominous. Considerable
emphasis is being placed on computer- based registers which will
be restricted to women who have indicated that they wish to be
part of the programme. Apparently no information will be put on
these registers without the signing of written consent forms on
every occasion.
The full potential of cervical
screening can only be realised with effective systems to invite
all women for screening, and to check that appropriate action
has been taken on positive results. Computer-based schemes appear
to offer the best opportunities and the main characteristics of
successful programmes are that they consumer oriented but service
initiated Schemes based on inadequate registers are doomed to
fail."
5.130 In May 1990 the National Cervical Screening
Programme Expert Group recorded in its report to the Minister its
support of Professor Skegg’s article. It went on to recommend that
the Programme should be designed to allow automatic participation
in the Programme with the ability to opt out, and that legislation
to enable this to occur should be passed. The opt-off option was supported
because it was considered it would encourage greater participation
in the Programme, provide greater choice, provide greater ability
to assure quality, result in less data fragmentation, and allow the
identification of targeting requirements to provide a better basis
for policy development. It is difficult to see why the initial opt-on
registers ever found favour.
5.131 In November 1991 the Associate-Minister of
Health endorsed a requirement for legislation to bring about an opt-off
register for the Programme. This required an amendment to the Health
Act 1956; the amendment was passed in 1993. Once the Register became
an "opt-off" register there was a dramatic increase in enrolments,
and therefore data. Overnight, 80-99% of all smear results from various
laboratories were being forwarded to the Register (as opposed to 20-40%
prior to the introduction of the legislation). Enrolments rose to
55% of eligible women in 1994, 69% in 1995 and 81% by 1996. The Committee
was told that by the end of the calendar year in 1999, enrolments
on the Register had risen to 91% with 84.6% having had a smear in
the previous 5 years. This exceeded the projected target set in the
1996 Policy and compared well with cervical screening programmes
internationally. However, the use of an "opt-off" register
only became possible by 1993 and then it was caught up with the need
to reconfigure the register into a national register. The impact of
this was that it was not until after Dr Bottrill retired that the
Programme was able to generate information from the register that
gave any reliable indication of a laboratory’s diagnostic performance.
5.132 The Programme began with a register system
that was sub-optimal. The system did not become fully effective until
1997 when it was reconfigured into a national centralised register.
Although it was recognised early in the Programme that the system
of 14 stand-alone registers was not operating effectively, and that
this in turn was having a detrimental impact on other facets of the
Programme, it took until 1997 to reconfigure the registration system
into an optimal form. The system’s two major flaws were features which
were contrary to all the expert advice that was available during the
time the Programme was being set up. The Committee considers that
the detrimental impact the sub-optimal registration system had on
the Programme is perhaps best explained in this interchange between
the Committee and Ms Grew.
"Q When you look back now
it seems that all the work, however well intentioned it was from
the outset up until 1993, has turned out to be misplaced in the
sense that all the work that went into setting up 14 different
registers, being opt-on registers, then had to be redone with
the national Register in circumstances where it was opt-off, which
was one of the early recommendations coming through from the expert
group.
A All I can say … is that there
were some givens. My job was to set up the Programme within the
constraints already in place and that is that there were 14 registers.
I did get policy approval to look at rationalising those down
to one, so it was clear even in the very early days that we were
asked to set up something that was not ideal at the end of the
day, and my first job really was to set up something and then
obtain approval to change it so that it was more effective."
(emphasis added)
With a sub-optimal registration system the Programme
was never going to operate effectively; in particular the registration
system could not be used to monitor the performance of laboratories
and so it could not be used to detect under-reporting. Professor Skegg
told the Committee that he found it " extraordinary [that] we
have spent millions of dollars each year establishing and maintaining
these registers [the National Cervical Screening Register and the
Cancer Register] but we are not using them in they way they could
be used to advance the health of women." In the Committee’s view
the sub-optimal character of the National Cervical Screening Register
and the impact it had on the effectiveness of the Programme is a factor
that is likely to have led to the unacceptable under-reporting that
occurred in Gisborne.
Failure To Put In Place Laboratory Performance
Standards And To Make Reliable Data Available
5.133 Throughout the time that Dr Bottrill was in
practice at Gisborne Laboratories the National Cervical Screening
Programme had no laboratory performance standards in place and it
had no reliable data. Therefore, it was not possible to monitor and
evaluate laboratories’ performance. Without doing this it was not
possible for those responsible for the Programme to detect incidences
of unacceptable under-reporting.
No Laboratory Performance Standards
5.134 There was no dispute from any of the witnesses
heard by the Committee that performance is more easily measurable
if standards are in place. By performance "standards" the
Committee means quantitative benchmarks which a laboratory must achieve
as opposed to something which a laboratory should aspire to achieving.
Performance standards are a measure against which those monitoring
performance assess whether or not a laboratory is performing according
to expectations. Performance standards specify the expectations of
a health service. Without performance standards it is not possible
to monitor adequately, if at all. The importance of this has always
been well recognised. From the evidence the Committee heard there
appeared to be no dispute that monitoring, if it is to be done properly,
requires the imposition of performance standards. Professor McGoogan
told the Committee that it was very difficult to evaluate data without
pre-set standards. In addition, it was difficult to measure quality
of performance without pre-set standards. In Professor McGoogan’s
opinion, the absence of standards did not reflect well on the New Zealand
Programme:
"Q Could you offer an opinion
on the New Zealand approach to creating the national average and
how that would impact on one’s evaluation of laboratory practise
relative to the national average?
A I’ve said before in evidence
that the measurement of quality is the degree to which one conforms
to pre-set standards. The three statistical reports provide interesting
data about what is happening to women in New Zealand who
are registered with the screening Programme, but it is very difficult
to evaluate this data without a standard against which to compare
it. It seems to me these standards have never been set.
Q Well it appears that a standard
may have been set for laboratory reporting by pooling the results
of all laboratories and creating an average.
A The principle is an average
if New Zealand wishes to set its standard as the average of all
the laboratories. It number one should say so and number two it
should justify it. When one makes an average you take a wide range
of laboratories whose practice may differ enormously, and averages
notoriously hide excellent practice and very poor practice within
them. That was the specific thing we wished to avoid in the UK
in setting the standard in 95.
Q What does it tell you about
the New Zealand Programme if there were no standards set?
A Unfortunately it does not reflect
well on the New Zealand Programme. There seems to be a belief
that simply doing the work is good enough, not necessarily doing
it to a high standard or at least an acceptable standard … Again
I’m very impressed with the effectiveness of the New Zealand
Cervical Screening Programme. You have reduced the incidence of
cervical cancer in both your Maori population and in the rest
of your population, so your screening Programme is effective,
but without quality standards in place you cannot evaluate how
much more effective it might have been.
5.135 In New Zealand the importance of having performance
standards for laboratories reading cervical cytology was recognised
as early as 1989. Section 8.13 of the Report Of The Ministerial
Review Committee On Implementation Of A Government Policy for National
Cervical Screening, which was published in November 1989, recommended
the development of a set of minimum standards of competency for laboratories
and smear readers. An example of overseas authority supporting the
need for performance standards is the European Guidelines for Quality
Assurance In Cervical Cancer Screening published in 1993:
"A pre-condition of quality
assurance is the establishment of standards. The aim of the quality
assurance programme is to ensure that these standards are met."
5.136 A departure from the view that performance
standards are essential for a programme can be seen from the minutes
of the Cervical Screening Liaison Advisory Committee on 26 July
1995. At the meeting there was discussion about analysis of laboratory
statistics which were contained in a draft report of the Programme’s
performance (the Second Statistical Report). Copies of laboratory
statistics had been taken from the draft report and circulated to
the members of this committee. Those who were present at the meeting
on 26 July 1995 are recorded in the minutes as agreeing to each laboratory
being supplied with its individual statistics for comparison with
national ranges and averages produced in the draft Second Statistical
Report. This committee thought it was too early to set performance
standards as it considered that appropriate statistical ranges were
yet to be established The minutes recorded that:
"One of the problems with
assessing laboratory performance is that the appropriate statistical
ranges for cytology screening have not yet been established. Cytology
is a very subjective science and it is difficult to set numerical
standards. There is a danger that any standard set would be so
wide that they are hardly worth setting.’
5.137 However, the Committee considers that this
was insufficient reason to delay the setting of performance standards
as these are not dependent on knowing the statistical range of laboratory
reporting. The use of national averages to measure individual laboratory
performance was criticised by Professor McGoogan. She pointed out
to the Committee that the difficulty with taking a national average
is that over a wide range of laboratories practice may differ enormously,
and averages can hide excellent practice and poor practice within
them. She said that was the very reason why in the United Kingdom
they chose to set a performance standard instead. The Committee can
see the wisdom of the United Kingdom approach. It seems, however,
that the Cervical Screening Liaison Advisory Committee was not as
alert as Professor McGoogan was to the masking effect of using a national
average to provide a measure of comparison for a particular laboratory.
5.138 The Committee has heard other evidence about
the importance of performance standards. The Committee rejects the
view expressed by the Cervical Screening Liaison Advisory Committee.
It considers that as at 1995 there was sufficient authoritative material
from overseas to provide a guideline for setting appropriate numerical
standards. It was unnecessary for any numerical standards that were
set to reflect the performance of New Zealand laboratories; that
approach belies the whole basis of having performance standards. Appropriate
standards should be set according to objective measures of good performance
and laboratories should be required to meet those standards. It is
not a matter of discovering how laboratories are performing and then
tailoring standards to reflect the average performance. Furthermore,
to use the national average rate for reporting abnormalities as a
standard is dependent on the assumption that the national average
rate is in itself an appropriate benchmark. For example, if all New Zealand
laboratories had been under-reporting to a greater or lesser degree,
then the national average would in itself be a poor performance standard
and to attain it would be falsely reassuring. New Zealand laboratories
should have been required to ensure that their performance met numerical
standards similar to those in place for cervical screening in overseas
programmes. There is no reason why a New Zealand cervical screening
programme should adopt lower performance standards for laboratories
than programmes in other countries. New Zealand could have done
the same as the United Kingdom. In addition, the view of the Cervical
Screening Advisory Committee overlooks the importance of pre-set standards
for monitoring and evaluation. If the Advisory Committee thought the
subjective character of cytology made it too difficult to set numerical
standards, it is hard to imagine how the Committee contemplated the
Programme could be monitored and evaluated. The Advisory Committee’s
comments demonstrate to the Committee how unaware the Advisory Committee
must have been to what thorough monitoring and evaluation of the Programme
entailed. It is clear to the Committee that Professor McGoogan saw
no value in the New Zealand approach:
"Q You had the opportunity
to look at the three statistical reports produced by the New Zealand
Programme, and I am sure you have noted the laboratory reporting
rates in the table. From those tables you can see that the New Zealand
average for reporting rates of various pap smear abnormalities
have been determined by including all laboratories that are reporting
and then determining the average and the minimum and the maximum.
A Yes.
Q Now this contrasts with the
approach that the UK took, which was to take the practice of 12
quality laboratories and to use their results to establish their
benchmark. Is that correct?
A That is correct.
Q Could you offer an opinion on
the New Zealand approach to creating the national average
and how that would impact one’s evaluation of laboratory practise
relative to the national average?
A I’ve said before in evidence
that the measurement of quality is the degree to which one conforms
to pre-set standards etc."
5.139 Throughout the time that Dr Bottrill was in
practice no laboratory performance standards were in force. This was
recognised by the Health Funding Authority when, as a result of the
under-reporting at Gisborne, it came to review the performance of
other laboratories. It identified certain factors relating to the
Programme including:
"The lack of specific standards
or targets for cervical cytology in New Zealand during the period
covered by … [the] review.[1990-99];
5.140 The Government Policy for National Cervical
Screening 1991 provided that performance indicators for area health
boards were to be developed by the Department of Health and negotiated
with area health boards. The 1993 updated Policy provided that
performance indicators for regional health authorities would be developed
by the Ministry of Health and Public Health Commission and negotiated
with regional health authorities. In the course of the Inquiry the
Committee’s attention was never drawn to the performance indicators
for area health boards. The Committee considers that it can be safely
assumed that if such indicators had covered laboratory performance
then they would have been brought to the Committee’s attention. As
regards performance indicators for regional health authorities, these
were specified in the funding agreements and related purely to waiting
times for colposcopy examinations, enrolment of women and improving
access to screening and treatment services. No performance indicators
were ever developed in relation to laboratory reading of cervical
cytology. It is clear to the Committee that the provision in both
Policies for the development of performance indicators, which
the Committee assumes to be a diluted version of quantitative performance
standards, was recognition that some measure of performance was necessary
to enable the Programme to be monitored and evaluated. It is unfortunate
that nothing was done to develop performance indicators for measuring
laboratory performance.
5.141 Ms Glackin told the Committee that she considered
it was not true to say there were no standards for the Programme.
She accepted that there were no quantitative performance standards.
However, she said this did not mean there were no standards in place.
She pointed to the National Cervical Screening Programme Policy
of 1996, which she said had expectations in a large number of
areas associated with the Programme. Inevitably it seems to the Committee
that responses from witnesses may turn on semantics. To the Committee
an expectation is not a standard. A standard is something which must
be adhered to and which is capable of being enforced. When it came
to laboratory performance there was nothing of this nature in place
throughout the time Dr Bottrill was in practice, and even after that
time. It is only since the Health Funding Authority commenced working
on setting performance standards that standards, which are capable
of measuring performance and being enforced, have been formulated.
The 1996 Policy, which came into effect after Dr Bottrill had
retired did not contain compulsory standards capable of measuring
laboratory performance.
5.142 The Committee considers that the failure from
1990 to 1996 to impose performance standards on laboratories reading
cervical cytology is a factor that is likely to have led to the unacceptable
under-reporting in the Gisborne region. Without performance standards
the laboratories could not be adequately monitored, and, therefore
it was impossible to be sure that they were reading cervical smear
tests adequately. Furthermore, a requirement to meet set performance
standards would have been a signal to Gisborne Laboratories that laboratory
performance could be measured against those standards. Performance
standards coupled with sanctions for failure to meet the standards
would have caused Gisborne Laboratories either to improve its practices
or to cease reading cervical cytology.
No Reliable Data
5.143 For the effective operation of a screening
programme it is essential to have timely and reliable data available.
This enables an analysis of the Programme’s performance to be undertaken.
Within this context the availability of reliable data on laboratory
performance in reporting cervical smear tests enables those who are
responsible for the Programme to detect if any misreporting is occurring.
If the data is made available to laboratories it enables them to analyse
the quality of their performance and to discover errors. The importance
of statistical data for monitoring and evaluating a cervical screening
programme was recognised in World Health Organisation Bulletin of
1986 titled Control of Cancer of the Cervix Uteri; the World
Health Organisation’s Cervical Cancer Screening Programmes Managerial
Guidelines of 1992 and the European Guidelines for Quality
Assurance In Cervical Cancer Screening. The last publication sets
out 18 different tables for tabulating data required for monitoring
a cervical screening programme.
5.144 Throughout the time that Dr Bottrill was in
practice, no reliable data on laboratory performance was available.
This meant that Dr Bottrill never received any information from the
Programme that could have alerted him to the possibility that he was
under-reporting an unacceptable number of cervical smear tests. Dr
Bottrill told the Committee that he thought he was detecting a reasonable
number of high-grade abnormalities each year.
" Q: … you didn’t know how
your results compared with anybody else did you?
A: No
Q: In 1995?
A: I didn’t. However, I was seeing
about 30 high-grade lesions a year and without knowing any statistics
it seemed a reasonable sort of number for the population we were
dealing with. I can’t go any further than that because the figures
just weren’t available.
The lack of statistical data also meant that those
responsible for the Programme were unable to detect if any of the
laboratories reading cervical cytology were misreporting the results.
5.145 The National Cervical Screening Programme was
unable to produce reliable data for the period before 1993 because
no meaningful data could be derived from the "opt-on" registers
then in use, due to the number of registrations not providing a sufficient
sample of the population. Secondly, until the 14 stand-alone registers
were reconfigured into a centralised register the data was not reliable
due to the confounding effect of women being recorded on more than
one register. Ms Grew told the Committee that when she was national
co-ordinator she could recall some early statistical information on
laboratory performance. However this information had not been published
and she agreed that it was because the data was not considered to
be sufficiently robust. When the Committee asked for a view from the
past national co-ordinators about whether or not there had been minimal
monitoring and feedback provided by the Programme Ms Grew’s response
was:
Ms Grew "I’m just struggling
to remember that data that I referred you to earlier, that laboratory
data – I do recall there was concern obviously because then numbers
were so small and it was decided definitely not to publish them
but I may be wrong, but I understand each laboratory was going
to get its own but I don’t know what – I can’t imagine what value
it could have been, given there was not the ability to sort of
compile a national average or anything like that that was reliable."
5.146 It was not until 7 August 1996, by which time
Dr Bottrill had retired from practice, that statistical information
about laboratory performance in the form of the 1996 National Cervical
Screening Programme Statistics first became available. The forward
to these statistics recorded that it had always been the intent of
the Programme to provide laboratories with information, but that until
recently the Programme had insufficient data to allow meaningful analysis
for most laboratories. These statistics were intended to provide an
analysis of all cervical smear tests stored on the Registers to the
period June 1994. The evidence the Committee heard was that information
began to be recorded in 1990, therefore, it can be assumed that the
1996 statistics cover the period 1990 to 1994.
5.147 The period from 1990 to 1994 was a time when
Dr Bottrill was practising at Gisborne Laboratories. Therefore,
the statistics are relevant in that they provide a reflection of Dr Bottrill’s
performance in comparison with other laboratories. The forward to
the statistics stated that:
"The intent of the report
is to provide information to be used in the your [sic] laboratory’s
quality assurance processes. One of the NCSP’s major principles
has been the implementation and emphasis on quality assurance
with the aim to reduce the number of false negative results."
(emphasis added)
5.148 Interestingly, the statistics place Gisborne
Laboratories’ reporting rates within the acceptable range. They recorded
that 86% of the smears read at Gisborne Laboratories were reported
as being within normal limits. The average rate for community laboratories
making these reports was 80.9% and the range was 68.7-94.7%. Gisborne
Laboratories was recorded as having reported 0.6% of abnormalities
with high-grade codes. The average rate was 0.8% and the range was
0.4%-2.0%. Thus, if Dr Bottrill had received these statistics while
he was in practice, they would have shown him that there was nothing
exceptional or unacceptable about his reporting rate. They would have
given him no cause for concern about the accuracy of his reporting.
Indeed they are likely to have reassured him that his performance
was competent.
5.149 However, in the course of the Inquiry the Committee
has been told by a number of witnesses that the 1996 National Cervical
Screening Programme Statistics were unreliable. Mr Du Rose of
the Health Funding Authority accepted that they were unreliable and
said he would not put a lot of weight upon them. He accepted that,
in a national monitoring exercise, they would not have been a helpful
indicator. He also agreed that they could be falsely reassuring. For
example, Dr Bottrill’s false negative rate was within the acceptable
range and it was not the lowest rate recorded. Mr Du Rose also
accepted that the statistics may well have been falsely reassuring
to members of the Royal College of Pathologists of Australasia when
issues were raised about whether or not there should have been a review
of cervical cytology from the Gisborne region.
"Q Given that it is accepted
that there will always be false negatives in cytology, reading
a statistical report which shows that generally the readings from
the laboratory within a certain period of time have been within
the range, again could be falsely reassuring, it could make you
think if there was a problem with a couple of slides, its just
a false negative problem, as opposed to a bigger problem, do you
agree?
A Yes, its possible, yes. I think
it also points to the lack of not having something where you are
actually measuring against."
"Q From the perspective of
a pathologist working a laboratory presumably not thinking a lot
about statistical information all the time, having a document
like that (the statistics) come in through the mail to him, looking
at it seeing that his reporting rate is within a similar range
to other laboratories, I suggest that it’s likely to reassure
him that his practices are okay, rather than to signal to him
there could be a problem.
A Yes I agree."
5.150 Professor Skegg was also critical of the 1996
National Cervical Screening Programme Statistics. He was concerned
that the statistics took no account of the underlying prevalence of
cervical cancer; they did not record whether or not the cytology diagnoses
were accurate; as at June 1994 fewer than 50% of women eligible for
screening were recorded on the Register/s. He said that the opt-on
character of the Registers may have confounded the data, as in his
view, the type of women who opt-on to a register have been found to
be at a lower risk of cervical cancer than those who do not choose
to go onto a register. He also said that the data were based on the
number of smear tests which were reported in different ways and not
on numbers of women. This meant that no account was taken of the presence
of more than one smear test for the same woman. Variations in medical
practice could mean that in a particular circumstance some clinicians
would take more than one smear and others would not. If two smears
were taken from the same woman within a short timeframe, and they
were both reported as abnormal, this would influence the overall proportion
of smears reported as high-grade. Professor Skegg was very critical
of statistical analyses based on the numbers of smears rather than
numbers of women:
" I think analyses based
on the numbers of smears rather than numbers of women are fraught
with problems."
5.151 Professor McGoogan also found the 1996 National
Cervical Screening Programme Statistics unhelpful. She considered
that no conclusions could be drawn from them:
"Q What are your concerns
about this document?
A Well it’s not clear whether
this is cumulative year on year data or whether it refers to a
shorter period of time. In an opt-on register situation the early
years are likely to have fewer smears than later years. Laboratories
reporting fewer than 1,000 smears are excluded. If a laboratory
reported 1,000 in the last six months it would be excluded from
the starter. I note it doesn’t tell me whether – this is a smear
collection statistic, it doesn’t tell me anything about women
– about whether you have had one smear per woman or ten smears/women
in this period of time. If there had been repeated smears from
normal women at six monthly intervals for example, it could sway
the results. The corollary is if we were reporting smears from
the women with high-grade abnormality as she passed through different
caregivers, but the smears were sent to the same laboratory, that
would also skew the results. Unless the statistics are collected
in such a way to avoid these biases then it is difficult to make
any comparisons between laboratories simply by looking at smear
numbers. I am also concerned that the community laboratory range
starts at naught (zero) for various things – I’m not sure how
meaningful therefore the range is as a means of comparison of
the laboratory in question."
Q You are saying then that without
some standardisations and explanations of the data collected and
who the population is, it is not very beneficial.
A I don’t think you can draw any
conclusions from it. In the UK for example there are some colposcopy
services who prefer to take a repeat cervical smear the first
time they see a woman in the clinic. Laboratories are required
to remove those from their reporting profiles so they are not
duplicating two abnormal smears from one woman in their reporting
profiles before they submit their statistics, so that they don’t
build in a bias, so its very important when collecting the statistics
that you collect the same thing from each laboratory or at least
you know when you are not."
5.152 It was the lack of statistical information
which had a negative impact on the performance of Gisborne Laboratories
and that is a factor that is likely to have led to under-reporting.
The 1996 statistics had no impact on the practice at Gisborne Laboratories
as they did not become available until after Dr Bottrill had
retired. They did, however, have a negative impact when it came to
deciding if a review of all of the smears read at Gisborne Laboratories
was necessary. Their impact on the Royal College of Pathologists of
Australasia is most concerning. When the Health Funding Authority
sought the views of the College on a review of the cervical smear
tests from the Gisborne region the College’s response was influenced
by the 1996 statistics. It used these statistics to compare the rates
at which different laboratories around the country had reported abnormalities.
Because Gisborne Laboratories’ rate was not significantly different
from the national average, and because Gisborne Laboratories did not
have the lowest reporting rate, the College went so far as to say:
"Dr Bottrill exceeded the
performance of almost one fifth of Australian laboratories judged
by today’s standards."
At the time the College was unaware of the deficiencies
in these statistics. It was only in the course of the inquiry when
a number of expert witnesses were asked to look closely at these statistics
and to comment on their usefulness that their unreliability was recognised.
However, the detrimental influence the statistics had on the judgment
of the College when it came to advise on the need for a review shows
how dangerous and damaging unreliable statistics can be. If the Health
Funding Authority had decided to follow the College’s advice there
would have been no review of the smear tests by Douglass Hanly Moir
Pathology and the unacceptable level of the under-reporting at Gisborne
Laboratories may not have been revealed.
5.153 Apart from the 1996 National Cervical Screening
Programme statistics which were sent to each laboratory, there were
a total of four official statistical reports for the Programme which
the Ministry published. Three of these were general reports and the
fourth was a Maori statistical report. The first statistical report
was dated 18 August 1992 and it was released in August 1993. The second
statistical report was an analysis of data to 30 June 1994 and
it was released in October 1995. The third statistical report was
an analysis of data to 31 December 1995 and it was released in
1998. The Committee was interested to hear how helpful these statistical
reports would be to a pathologist wanting statistical data to determine
whether or not his or her laboratory was providing a quality service
in terms of smear reading. The Committee was told by Professor McGoogan
that she would not have found any of the three statistical reports
helpful.
"Q First, can you tell me
as a pathologist, are those reports – would those reports be helpful
to you in deciding whether or not you were happy with the performance
of smear reading in your laboratory?
A It wouldn’t help me at all."
5.154 Professor McGoogan was then questioned about
the timeliness of the data. Professor McGoogan informed the Committee
that it was important for a pathologist to receive statistical information
which was close enough to the period of time for which the analysis
was made to allow the pathologist to make adjustments to his or her
performance. She considered that an annual supply of statistical analysis
of a laboratory’s performance was appropriate. Her reaction to the
timeliness of the three statistical reports differed. In her view
the first statistical report was understandably the best that could
be delivered at that particular time, given the nature of the opt-on
register, and also it was delivered a year after the period for which
the analysis was made which was not unreasonable. The second report
was delivered in October 1995, which was two years later, but it dealt
with data to June 1994, therefore there was a 15-month delay in delivering
the information. Professor McGoogan described this as "not too
bad but drifting out from what is being helpful if one thinks that
a practice needs to be improved or adjusted". She also pointed
out that if other statistical information needed to be collected,
it was already too late to do so, and as the second statistical report
was delivered in October 1995, any new or better statistics could
only be collected thereafter. She was particularly disappointed with
the third statistical report. Her description of this report was as
follows:
"It is extremely disappointing
that the third report, which dealt with analysis of data up to
the end of December 95 took until June 98 to be delivered. It’s
further disappointing that the quality of the statistical information
leaves a lot to be desired and the authors of the report have
done their best to identify the limitations of the quality of
the information in the report. While producing the statistics,
it’s simply telling you what the data is on the Register, but
not saying it is perfect, so how do you interpret it?"
"Q As a pathologist wanting
to measure the performance of your laboratory how helpful are
each of these reports?
A Not very helpful, particularly
the last one is very unhelpful."
5.155 Professor McGoogan did not evaluate the Maori
statistical report. She did, however, comment that the bigger the
database the more accurate the conclusions drawn from it, and the
smaller the database the more difficult it is to derive meaningful
and significant statistics. She, therefore, thought the numbers in
the Maori statistics may not be large enough and, although of interest
to Maori to see what was happening to them, there may have been insufficient
numbers to allow meaningful conclusions to be drawn. When asked by
the Committee to comment on the fact that the Maori statistical data
was at least four years old when first published in the Maori statistical
report, Professor McGoogan’s response was:
"It may have been useful
four years ago, but it doesn’t tell you whether things are different
now, better now, or worse now, and we need to know what’s happening
now."
5.156 The Committee learnt that annual statistical
reports were intended. However, their publication was hampered by
the difficulties that the Programme encountered in obtaining reliable
data. This was due to the fragmentation that resulted from having
14 stand-alone registers. Secondly the involvement of 14 area health
boards had a detrimental effect. The Committee learnt that some of
the area health boards altered the software of the registers in their
regions and this affected the collection of statistical data. Secondly
the number of area health boards allowed room for divergence in viewpoints
to arise which led to actions differing from region to region. For
example the first statistical report, which was released in August
1993 and which presented data to 18 August 1992, was first of all
delayed, because the Wellington Area Health Board would not provide
data from its region, and finally the report was published without
data from Wellington. The release of the Wellington data was held
up by the security protocols of the Wellington Area Health Board’s
Ethics Committee. Furthermore, the Programme delayed issuing a second
statistical report until the Wellington data became obtainable. The
second statistical report was released in October 1985 and it presented
data to June 1994. It could not present data beyond that date because
no data from the Auckland Area Health Board region was available beyond
June 1994. The third statistical report was released in June 1998
and it presented data to December 1995. Professor McGoogan, Professor
Skegg and Dr Cox were critical of the statistical reports in
terms of their limited value for methodological reasons, and also
because the data was well out of date by the time the reports were
published. When those criticisms were put to Ms Grew her response
was that not having one database made it very difficult to produce
statistical reports. Her view was the first statistical report was
affected by lack of data, but she thought that subsequently it should
have been possible to have got into a routine, and once there was
only one database it should have been "really easy to produce
an annual report or even three monthly, six monthly". Ms Grew
was then asked to explain from her perspective as a former national
co-ordinator of the Programme why it was that only three general statistical
reports had been produced. She could not offer an explanation. Ms Dahl
said that until the register was reconfigured into one database it
was too difficult.
"Q From your perspective
are you able to explain why there have only been three statistical
reports in the period?
A – Ms Grew I can’t explain that.
A – Ms Dahl I can explain it was
very difficult to do the second statistical report and that related
to the fact that we did have 14 registers at the time. We had
to create programs to get the information downloaded at the 14
sites and compiled in Wellington so that we could do that reporting.
I would have envisaged that once we had the register reconfigured
that the data would be more readily available and it would have
been an easier thing to do."
5.157 There was also no compulsory requirement to
report incidences of cancer and deaths from cancer until the passing
of the Cancer Registry Act 1994. An effective Cancer Registry is essential
to enable a screening programme to be monitored and evaluated. One
way of testing the effectiveness of a screening programme is to carry
out an audit of the cases of cancer by retrospectively investigating
the smear history and clinical treatment of the women concerned. To
do this there needs to be a reliable record of the number of cases
of cancer. On 5 April 1990 the Expert Group wrote to the Minister
of Health advising her of the urgent need for up-to-date statistical
information on cancer cases. The letter stated:
" The Expert Group is resolved
that it is impossible for it to adequately perform its task if
the Cancer Registry is not adequately functional. The Expert Group
therefore recommends as a matter of urgency the Cancer Registry
is resourced with equipment, staff and legislative framework to
provide a complete up-to-date and confidential registry of all
cancers and cervical dysplasias in New Zealand."
Ms Gillian Grew who was the first national co-ordinator
of the Programme was asked if she was aware of the Expert Group’s
views and whether or not she agreed with them. She said she was aware
of their views and she agreed with them:
"Q Were you aware that the
Expert Group had that concern and what to your knowledge was done
about it?
A Ms Grew: I was aware when I
arrived in the department that they had a concern and there was
quite a lot of work going on to actually secure the future of
the Cancer Registry at that time.
Q Do you agree with the sentiments
in the letter
A Certainly. "
5.158 Other experts from whom the Committee heard
evidence also thought that a cancer registry was necessary for the
Programme to function effectively. Furthermore, this type of advice
in various forms was both available and given to the Department of
Health during the developmental stages of the Programme. This is stated
in the World Health Organisation Bulletin of 1986 titled Control
of Cancer of the Cervix Uteri; the World Health Organisation’s
Cervical Cancer Screening Programmes Managerial Guidelines of
1992 and the European Guidelines for Quality Assurance In Cervical
Cancer Screening. However, it was not until 1994 that the legislation
setting up a cancer registry with mandatory reporting provisions was
passed. Since then there have been problems with the completeness
of the Cancer Registry data. In addition during the course of the
Inquiry the Committee learnt that the Cancer Registry was not releasing
data in accordance with the law and was imposing an unnecessary obstacle
by requiring compliance with the Health and Information Privacy Code,
even though the Code had no application to processing requests for
Cancer Registry information.
Failure To Conduct Any Comprehensive Exercise
To Audit, Monitor And Evaluate The Performance Of Laboratories Reading
Cytology
5.159 It is important to be clear about the meaning
given to the words "auditing," "monitoring" and
"evaluation" as their meaning can differ depending on the
user. The Committee has chosen to adopt the definition of these words
that is set out in exhibit JMP/HFA/0023, the November draft of the
Health Funding Authority’s Evaluation and Monitoring Plan for the
National Cervical Screening Programme. "Monitoring" means:
"…the continuous supervision
of an activity for the purpose of checking whether plans and procedures
are being followed.
Within the meaning of "monitoring" is the
act of "auditing" which is:
"a subset of monitoring and
…[is] an investigation into whether an activity meets explicit
standards, as defined by an auditing document, for the purpose
of checking and improving the activity audited
"Evaluation" means:
" a comparative assessment
of the value of an intervention, in relation to criteria and using
systematically collected and analysed data, in order to decide
how to act.
"….other purposes of evaluation
…[are]:
a systematic way of learning from
experience and using lessons learnt to improve current activities
and promote better planning by careful selection of alternatives
for future action.
Programme evaluation is a diligent
investigation of a programme’s characteristics and merits. Its
purpose is to provide information on the effectiveness of projects
so as to optimise the outcomes, efficiency and quality of health
care."
Throughout the time that Dr Bottrill was in practice,
and subsequently, the National Cervical Screening Programme has not
carried out a comprehensive evaluation of its overall performance,
including the performance of laboratories reading cervical cytology.
Nor has it monitored the performance of laboratories reading cervical
cytology. The Ministry of Health took steps in 1995 to have a national
evaluation of the Programme carried out by an independent team of
experts but as at September 2000 this national evaluation was incomplete
and there are uncertainties still as to when, and in what form it
will be completed.
5.160 When the Health Funding Authority recognised
that the level of under-reporting at Gisborne Laboratories suggested
there was a significant problem with its smear test reporting, the
Health Funding Authority reviewed the cervical cytology of other laboratories
which it had identified as being potential poor performers. This exercise
was a response to the problem that had arisen in the Gisborne region
and, although it provided information of a type which could come from
a monitoring exercise, it can not be seen as having been undertaken
for the general purpose of monitoring and evaluating laboratory performance.
The Health Funding Authority acknowledged this in its published report
titled Review of Cervical Cytology Practice in New Zealand Community
Laboratories: 1990-1999. The Review states: "…this
review does not represent a thorough assessment and evaluation of
the quality of cervical cytology services."
5.161 The Committee considers that the failure to
set up from the outset a National Cervical Screening Programme with
performance standards in place and with a means of gathering reliable
statistical data to enable laboratory performance to be monitored
and evaluated adequately are factors that are likely to have led to
Dr Bottrill’s under-reporting of cervical smear tests. The Programme’s
lack of performance standards for reading cervical cytology, and the
absence of reliable data, made it difficult to monitor and evaluate
laboratory performance adequately.
5.162 The importance of monitoring and evaluation
is made clear in the World Health Organisation Bulletin of 1986 titled
Control of Cancer of the Cervix Uteri which states: "A
cervical cancer control programme should not be initiated prior to
the establishment of adequate evaluation procedures. It is essential
to assess progress of the screening programme periodically both from
the procedural standpoint, to determine how effective the operations
actually are, and in terms of achievement, to analyse the extent to
which morbidity and mortality have been reduced in the population
group covered." The need for reliable data in order to monitor
and evaluate is clearly spelt out in the literature on cervical screening
programmes. The World Health Organisation’s Cervical Cancer Screening
Programmes Managerial Guidelines of 1992 state: "For evaluation
and monitoring purposes the data must be maintained in a form that
permits identification and linkage at an individual level, and the
information system should be so designed that it is accessible for
such purposes.". The European Guidelines for Quality Assurance
In Cervical Cancer Screening state that: " Before cervical
screening can be implemented mechanisms for gathering essential data
for the day to day operation of the programme and for statistical
purposes must be in place."
5.163 However, the lack of reliable data and performance
standards should not lead to nothing being done. When the Health Funding
Authority had to carry out the Review of Cervical Cytology Practice
in New Zealand Community Laboratories: 1990-1999 it overcame the
absence of performance standards by focusing "on the assessment
of risk to women by examining markers of possible under-reporting
of abnormalities." It recognised that this type of exercise did
not enable a thorough assessment and evaluation of quality in laboratory
performance to be carried out. Nevertheless, it allowed the Health
Funding Authority to obtain some information about the performance
of other potentially poor-performing laboratories. However, in the
case of the National Cervical Screening Programme even this type of
evaluation was not carried out.
5.164 It is of course possible that once the 1996
Cervical Screening Programme Statistics on laboratory performance
became available any evaluation of Gisborne Laboratories’ performance,
which covered the period prior to March 1996, may have failed to detect
under-reporting. Those statistics placed the laboratory’s reporting
rate within what the Programme was treating as an acceptable range.
The Committee heard expert evidence that this information was misleading.
This highlights the danger of attempting to monitor a programme by
poor methods. However, if the Programme had monitored and evaluated
laboratory performance adequately from an early stage, even by looking
for indicators of under-reporting as the Health Funding Authority
did, the extent of the under-reporting of cervical smear tests at
Gisborne Laboratories may have been detected much sooner. This would
have reduced the number of women affected by misread cervical smear
tests.
5.165 The Committee has already commented on the
failure to develop the performance indicators to which the Policies
of 1991 and 1993 referred. Both Policies in their sections
on evaluation and monitoring refer to the development of performance
indicators. The Committee has interpreted this reference to performance
indicators as an acknowledgement that some means of measuring performance
was essential to enable the Programme to be monitored and evaluated.
Nevertheless, no performance indicators were developed for the purpose
of measuring laboratory performance.
5.166 The Ministry of Health maintained that some
monitoring of the Programme was undertaken, although they conceded
that this monitoring gave no information on laboratory practice. The
Ministry also conceded that the National Cervical Screening Programme
had never been subject to a comprehensive evaluation. At the outset
of the Programme, when it came to laboratory practice in reading cervical
cytology there was a complete reliance on the professional integrity
of the medical practitioners responsible for the performance of this
service. No attempt was made to ascertain the accuracy of the practitioners
and those working under their supervision in reading cervical smear
tests. Although, at this time the Social Security (Laboratory Diagnostic
Services) Regulations 1981 were in force, there was no attempt to
utilise the authority they gave to inspect laboratory equipment and
apparatus in order to check on laboratories’ performance. The Committee
realises that the Ministry of Health now submits that this part of
the regulations is ultra vires. It will deal with this submission
under term of reference three. Nothing changed after the health reforms
in 1993; laboratory practice in reading cervical cytology was neither
monitored nor evaluated.
5.167 Both the 1991 and 1993 Policies provided
that the National Co-ordinator would be responsible for ensuring that
the National Cervical Screening Programme was monitored and evaluated
nationally, and that evaluation of projects and services nationally
would be co-ordinated by the Department of Health and subsequently
by the Ministry of Health. The Policy also provided that on
a regional level it was the responsibility of the area health board
and subsequently the regional health authority to monitor and evaluate
the Programme in their area. However, Mr Mules of the Midland
Regional Health Authority told the Committee that the Midland Regional
Health Authority could not carry out this role as it did not have
access to the necessary information to enable monitoring and evaluation
to take place. The information was held by the Department and then
subsequently the Ministry of Health. Once again, it seems to the Committee
that the design of the Policy did not reflect accurately the
capability of those given responsibilities under the Policy
to discharge that responsibility.
5.168 What is of most concern to the Committee, however,
is the failure of the Department of Health and subsequently the Ministry
of Health to monitor and evaluate the Programme at a national level.
Under the Policy the National Co-ordinator was made responsible
for ensuring that national monitoring and evaluation took place. However,
it is clear from the job description of the National Co-ordinator
and from the evidence the Committee has heard of the role, that she
had no authority to ensure that the national monitoring and evaluation
of the Programme was in fact carried out. The Committee considers
it is a design flaw of the Policy that it gave a responsibility
to the National Co-ordinator without ensuring that she had intrinsic
or extrinsic power to discharge that responsibility by requiring national
monitoring and evaluation to be carried out. Secondly, the Policy
imposed a responsibility on the Department of Health and subsequently
the Ministry of Health to co-ordinate the monitoring and evaluation
of the Programme. Again, the evidence shows to the Committee that
the Department of Health and subsequently the Ministry of Health was
unable, sometimes for practical reasons and other times for legal
reasons, to discharge this responsibility. The end result was that
although both Policy documents made provision for monitoring
and evaluation of the Programme at a national level, including the
monitoring and evaluation of laboratory performance, it never occurred
during the time that Dr Bottrill was in practice. Indeed, from
the evidence the Committee has received it seems that the first attempt
to carry out a national comprehensive evaluation of the Programme
is still incomplete. Dr Peters, who gave evidence for the Health Funding
Authority is the manager of the unit in which the National Cervical
Screening Programme has been housed since 1998. She accepted that
there still has not been a comprehensive evaluation of the national
Programme.
"Q Dr Peters, I understand
that you accept that at the moment there has been no comprehensive
evaluation of the nation Programme, is that correct?
A Yes."
5.169 She also informed the Committee that from her
perspective, quality standards and monitoring and evaluation were
just beginning.
"Q In respect of bringing
in quality standards, monitoring and evaluation, are you really
starting from scratch with the programmes in terms in that aspect
of it?
A Well I feel as though I am."
5.170 The Committee has learnt that there has never
been an audit of cases of cervical cancer even though this is considered
to be one of the most effective ways of measuring the effectiveness
of a cervical screening programme. As early as 1986 the World Health
Organisation in its bulletin on Control Of Cancer Of The Cervix
Uteri had stated that:
"Screening programmes
can be evaluated by their failures. Cases of symptomatic invasive
cancer of the cervix, and especially of advanced disease can
be regarded as failures of a screening programme. Knowledge
of the age distribution of such cases and of their screening
history provides information of the effectiveness of the programme
in reaching the intended age groups and the quality of the
screening being carried out."
This form of monitoring and evaluation is particularly
useful when a cervical screening programme has no performance standards
in place, however, it does depend on access to reliable data on cancer
incidence and mortality and smear test history. Apart from the World
Health bulletin the Committee was informed by: Professor McGoogan,
Professor Skegg, Dr Medley, Dr Peters, Dr Cox and Dr Teague
that an audit of cases of cervical cancer was the gold standard for
measuring the effectiveness of a cervical screening programme.
5.171 Such an audit has never been carried out in
New Zealand. An attempt has been made to carry it out as part
of the national evaluation of the programme, but that has run into
legal and ethical obstacles. Ms Glackin acknowledged the difficulties
that had prevented this exercise from being carried out in New Zealand
and said that Ministry of Health officials had understood that ultimately
this exercise would be carried out routinely.
"I don’t think there is any
disagreement about the advice that following people with cancer
through was a gold standard in relation to treatment. And in the
light of that I’m not sure what people – whoever was dealing with
this - felt in 1993, but you would have expected that issue might
have been addressed then.
5.172 If the Programme had carried out an audit of
cervical cancer cases by looking back at the cervical smear history
of women who had developed cervical cancer and investigating those
who were registered as having normal smear tests within a set time
frame, such as five years prior to diagnosis, that is likely to have
alerted the Programme to the likelihood that there was an unacceptable
level of under-reporting in the Gisborne region. However, for reasons
which will be covered in term of reference three, it appears that
access to the register for this purpose has not been permitted. In
any event it was not until December 1999 that the Ministry realised
there was a legal barrier to using the register as an audit tool.
This indicates to the Committee that no meaningful attempt had been
made to use the register in this way before then:
Question: The evidence of, certainly
Dr Cox was that this clinical audit or retrospective look at women
who developed invasive cancer should, as Ms Glackin said, be a
routine occurrence. Would you accept that if that had occurred
early on in the Programme the problems with s.74A would have been
understood much more quickly than it has been now"
Answer Ms Glackin: I would, but
I should make the comment that from a technical perspective there
are issues with having, apparently, sufficient numbers of women
enrolled to make evaluation feasible. One of the issues with this
programme is that until after the opt-off in 1993 we had quite
small numbers. So I understand there were some technical issues
about when the evaluation could be done.
This comment from Ms Glackin indicates the major
difficulties the Programme faced. Evaluation was not possible before
the Register became an opt-off single database. Once it could be used
for evaluation, which was by 1997 when it was reconfigured and had
sufficient numbers of women registered to provide meaningful data,
the Ministry discovered that s.74A of the Health Act 1956 posed a
barrier to using the Register for this purpose. The outcome is that
during the time Dr Bottrill was in practice the Register could not
be used effectively to allow laboratory performance to be monitored.
5.173 In June 1996, which was after Dr Bottrill had
retired a new Policy for the Programme was published.
This Policy is relevant because if it had been designed to
ensure that the Programme was effectively monitored it would have
revealed the extent of Dr Bottrill’s under-reporting earlier
than has happened and this may have meant that the high-grade abnormalities
or cervical cancers of some women were detected earlier and therefore
they may have been more responsive to treatment.
5.174 Like the earlier Policies the Policy
of 1996 provided that the main responsibility of the Ministry of Health
was to monitor and evaluate the National Cervical Screening Programme
and to monitor and analyse the state of public health regarding the
incidence of cervical cancer and associated risk factors in New Zealand.
The Policy also provided that regional health authorities were
responsible for monitoring and evaluating the Programme in each regional
health authority region. Once again, there was the difficult tension
between the Policy’s placement of responsibility for national
monitoring and evaluating on the Ministry of Health with the responsibilities
the funding agreements imposed on regional health authorities. Ms Glackin
said to the Committee that under the 1996 Policy it was a requirement
on the Health Funding Authority to purchase the Programme in line
with that Policy. However, the impact of the split accountability
between the Ministry of Health and the Health Funding Authority and
the design of the 1996 Policy meant that the regional health
authorities left monitoring and evaluating to the Ministry of Health.
"Q The difficulty was that,
Ms Glackin, we had evidence from Mr Mules that the regional
health authorities considered that under the 96 funding agreement
responsibility for monitoring and evaluating the Programme remained
with the Ministry of Health, and he referred to that in his evidence
to say this is why, as far as he was concerned, the Midland Regional
Health Authority did not consider that it had to do that because
it was looking at the screening policy documents and under those
policy documents responsibility for monitoring and evaluating
the Programme remained with the Ministry of Health.
A – Ms Glackin Yes, and that issue
of split accountability was actually canvassed in the 1996 review.
I think the Ministry has no difficulty with recognising the problems
that arose from that division. I would just make a point though
in relation to evaluation that the Ministry initially put funding
in its budget and began initial work on a formal evaluation in
1996."
It should be noted that the formal evaluation that
Ms Glackin speaks of is the one that is still to be completed.
5.175 Ms Glackin told the Committee that the evaluation
was first discussed in 1995 and the Ministry decided to proceed with
a national comprehensive evaluation in 1996. Tenders were put out
and in January 1997 a contract was signed with the University of Otago
for a scoping of the evaluation. The first draft of the evaluation
was received in May 1997 and that proved to be too expensive. There
was then much consultation about what should occur. Ultimately a shortened
form of evaluation was agreed covering three specific areas and a
contract to carry that out was signed with the Ministry in May 1999.
As at 6 August 2000, when Ms Glackin was giving her evidence
to the Committee, of the three areas to be evaluated one had been
completed, one had received Ethics Committee approval three weeks
earlier, and the third, which was the audit of cervix cancer incidence
and mortality, was not proceeding because of the difficulties in gaining
access to information. Had a national evaluation been carried out
anytime after Dr Bottrill’s retirement in March 1996 it ought
to have detected earlier the unacceptable level of under-reporting
in the Gisborne region. That knowledge should have led to women receiving
treatment earlier on and it may have avoided cancer mortality or severely
invasive treatment for cancer.
5.176 Without monitoring and evaluation it is impossible
for a pathologist to be aware of the accuracy of his or her reading
of cervical cytology. All screening programmes that involve analysis
of cellular material are dependent upon the accuracy and competency
of the practitioner responsible for reading the cellular material.
Unless the practitioner’s work is monitored and evaluated mistakes
are not likely to be detected until the deteriorating health of the
screening subject causes the practitioner’s work to be reviewed. By
that time it can often be too late to cure the patient, or if the
disease is still curable severely invasive treatment may be required
to achieve a cure.
5.177 The success of the National Cervical Screening
Programme depended on pathologists and other laboratory workers reading
cervical smear tests competently and accurately. If the Programme
had monitored the performance of laboratories reading cervical cytology
the unacceptable level of under-reporting at Gisborne Laboratories
would have been detected much earlier on and, therefore, fewer women
would have been harmed. Furthermore, the information gained from monitoring
laboratory performance could have been used to inform Gisborne Laboratories
that the cervical cytology read at the laboratory was not being read
competently. As it was, throughout the time that Dr Bottrill was in
practice at Gisborne Laboratories, neither Dr Bottrill nor any other
director or officer of the company was provided with information,
from any Crown body or agency responsible for the Programme, which
would have informed them that there was an unacceptable level of under-reported
cervical smear tests. The Committee considers that to run a screening
programme that is dependent on laboratories performing their role
competently without providing them with any feedback on their performance,
is a factor that can lead laboratories to under-report the tests they
carry out. Consequently it considers that the failure to provide this
information to laboratories is a factor that is likely to have led
to the under-reporting at Gisborne Laboratories.
Failure To Take Heed Of Overseas Screening Failures
5.178 Between 1993 and 1994 there were three incidents
overseas of a laboratory causing a failure in a cervical screening
programme by under-reporting cervical cytology. These incidents occurred
in Australia and the United Kingdom. The Cervical Screening Advisory
Committee brought these screening failures to the attention of the
National Co-ordinator of the Programme and the Ministry of Health,
and they were published in the National Cervical Screening Programme’s
newsletters. In addition in June 1994 a hospital pathologist at Goodhealth
Wanganui was found to have misread biopsy specimens. The pathologist
was 62 years of age and had been diagnosed with Parkinson’s Disease
in late 1993. A review of his work revealed that he did not participate
in quality assurance activities; he did not participate in continuing
medical education and he was working in an isolated environment. It
was recognised that all of these circumstances may have impaired his
work as a pathologist.
5.179 Given the information that was available about
the mis-reporting in Australia and the United Kingdom, and the findings
from the Wanganui investigation it is surprising that neither the
Programme nor any other unit within the Ministry of Health initiated
a review of New Zealand laboratories reading cervical cytology; particularly
those laboratories, like Gisborne Laboratories, which in some respects
resembled the practice at Goodhealth Wanganui. The Programme’s staff
would have known that laboratory performance in reading cervical cytology
had never been properly monitored and evaluated, so that the quality
of the laboratories’ performance was not definitively known. These
local and foreign incidences of laboratory error were a signal to
the Programme that laboratory error can occur and when it did it could
have a damaging impact on patients’ health. While the Programme had
no direct power to take any action against laboratories it was the
entity under the Policy which was responsible for ensuring
that the Programme was monitored and evaluated nationally and so in
the Committee’s view it should have responded by initiating a review
of laboratory performance.
5.180 The overseas screening failures occurred during
the time that Ms Dahl was the national co-ordinator. The incidents
were noted in the Programme’s newsletter. The Committee learnt from
Dr Cox who was on the Cervical Screening Advisory Committee that
after the second incident the Advisory Committee advised the national
co-ordinator (Ms Dahl) that this type of event could occur in
New Zealand and that appropriate quality assurance was needed
to minimise the risk of it occurring. Ms Dahl told the Committee
that she could not recall Dr Cox specifically saying that at
the meeting, but she did recall that at the time she was working with
the Advisory Committee to develop quality assurance processes, monitoring
processes, and evaluation processes so she said that she could only
surmise that it was considered as part of what was being done in relation
to that. When asked to comment on why the Programme did not respond
to the these incidents by initiating a review of laboratory performance
in New Zealand, her response was that the overseas incidences
of misreporting had not brought home to the Programme the need for
a review.
"Q When I asked Dr Cox whether
or not – I asked him both in respect of each article [in the Programme’s
newsletter] they provided a wakeup call, and he said they did,
and I then said well in view of the first two wakeup calls, once
a second had been received what do you think should have happened,
and he said as a matter of urgency I would expected a review of
laboratory practice processes to reduce the chances of a similar
event occurring in New Zealand. What comment do you have
on that?
A – Ms Dahl The only comment that
I can have is that the wakeup call was not sufficiently loud to
have that occur."
5.181 In his evidence Dr Cox referred to a Programme
newsletter of January/February 1993 which contained an article on
the accuracy of smear tests of 237 women referred to the Royal Hospital
for Women in Sydney for invasive cervical cancer. The article noted
that a worrying aspect was the number of patients whose previous smears
on review showed frankly malignant cells but were originally reported
as normal.
5.182 In a second Programme newsletter of March/April
1994 there was an article on a screening failure in Great Britain
which described how a group of 2,000 women were recalled in Grennock
where smears had been wrongly read for five years in a laboratory
described as understaffed, antiquated and isolated. Dr Cox said
that the Advisory Committee advised the national co-ordinator that
"This type of event could occur in New Zealand and that
appropriate quality assurance is needed to minimise the risk of such
an event occurring.".
5.183 The Midland Regional Health Authority did respond
to the Wanganui incident by writing to all of its laboratory providers
including Gisborne Laboratories. In his response Dr Bottrill told
Midland that the laboratory had applied for TELARC accreditation in
histopathology and cytology, he advised that he did not participate
in any external quality control programmes, but said that he did attend
at least one national or international conference or course every
year. He concluded his letter by stating "There is little likelihood
of a major misdiagnosis of the type you refer to in your letter."
5.184 Dr Malpass of the Midland Regional Health Authority
judged the response from Gisborne Laboratories to be unsatisfactory
and referred it to the Chief Executive, (Mr Mules), to determine
what action, if any, should be taken. Mr Mules decided that the
Regional Health Authority had no power to refuse to fund laboratory
services from Gisborne Laboratories. At the time the legal relationship
between the regional health authority and the laboratory was governed
by a notice issued under s.51 of the Health and Disability Services
Act. Mr Mules believed that the laboratory was not in breach of any
of the terms of the s.51 notice and there were no other sanctions
that the regional health authority could apply against it. For this
reason it seems no action was taken as a result of Dr Bottrill’s unsatisfactory
response, and the Midland Regional Health Authority conducted no investigation
into his laboratory’s practices or processes.
5.185 The Committee considers that s.51 of the Health
and Disabilities Act permitted regional health authorities to issue
notices which contained terms and conditions that gave to them the
power to require laboratories to adopt quality assurance measures,
including TELARC accreditation, and to suspend laboratories from receiving
payment if their services were a risk to public health. The Committee’s
reasons for reaching this conclusion are set out in the section of
the report on term of reference three. It was also possible to change
the terms and conditions of s.51 notices on the giving of appropriate
notice. Therefore, the Committee considers that the Midland Regional
Health Authority should have carried out an investigation of Gisborne
Laboratories. If the investigation had shown that action was warranted
the Midland Regional Health Authority could then have taken steps
under s.51 to change the terms and conditions of the notice to allow
for appropriate action to be taken.
5.186 The opportunity, in 1994, which the Programme
and the Midland Regional Health Authority had to uncover the presence
of unacceptable under-reporting at Gisborne Laboratories was missed,
with the consequence that Dr Bottrill continued to practise until
his retirement in March 1996. During this time more women had their
smears misreported and, therefore, they did not receive the appropriate
follow up treatment. In the Committee’s view the failure by either
the Programme/Ministry of Health or the Midland Regional Health Authority
to follow up the local and foreign incidents of laboratory error which
in turn led to a loss of opportunity to discover the under-reporting
at Gisborne Laboratories earlier is a factor that is likely to have
led to the under-reporting that occurred from 1994 onwards.
Failure To Ensure All Components Of The Programme
Were In Place From An Early Stage
5.187 There was a failure to ensure that all the
components of the National Cervical Screening Programme were in place
from the outset or, alternatively at an early stage in the Programme’s
development. If all the missing components had been in place from
an early stage in the Programme, that is: reliable statistical data,
performance standards, monitoring and evaluation of laboratory performance
and compulsory quality assurance of laboratories, they would have
prevented Dr Bottrill from practising as he did.
5.188 The need to have all the components of the
Programme in place from an early stage was recognised early in the
Programme’s development, by the Ministerial Review Committee in its
November 1989 report On Implementation Of A National Cervical Screening
Programme. The Ministerial Review Committee stated:
"For a cervical screening
programme to be successful all aspects must be developed simultaneously
as each is an integral part of achieving success."
5.189 Ms Glackin accepted this and told the Committee
that over time the Programme had been progressing towards having everything
in place.
"Q And do you agree this
really reinforces what the World Health Organisation was saying
to run a programme effectively you really need to have all aspects
in place at once, or if you are building up good data from the
cancer register and the screening register and you can make the
necessary links, and if you can make the necessary links between
cytology and histology all these factors go to help you identify
more readily cases where the programme might be failing in respect
of under-reporting of smear tests.
A – Ms Glackin I would agree with
that, and I think, looking over time what we have been doing is
progressing towards that state. I think the Inquiry is well aware
of how long various aspects of that have taken. I should perhaps
make the point of course which the Inquiry is well aware of, that
the cancer registry deals with cancers of all sorts."
However, the progress Ms Glackin referred to
is still to be completed. The re-configuration of the Register was
completed by 1997 and since that date reliable data should have been
available to monitor and evaluate the Programme. Compulsory TELARC
accreditation has been in place since 1997. However, there have been
other obstacles to surmount. The end result is that even today some
of the components are still missing. Reliable data is still hard to
access because of legal and ethical barriers and the Programme has
still not been comprehensively monitored and evaluated. This is ten
years after the Programme was operative in the Gisborne region.
No Compulsory Reassessment Of Medical Practitioners
5.190 There were no compulsory requirements for medical
practitioners to undertake formal continuing education, or for them
to have their competence reassessed. The Committee considers that
this too was a factor that is likely to have led to the unacceptable
under-reporting in the Gisborne region. Had Dr Bottrill been required
to undergo formal continuing education and a re-assessment of his
competency as a medical practitioner it is unlikely that he would
have continued to practice as he did. The impact of formal continuing
education could well have brought home to him the risk his practices
posed to patients. A re-assessment of his competency would most likely
have revealed that he was being overly cautious in diagnosing abnormalities;
that he had " calibrated" his eyes to read smear tests with
a very high specificity and that he needed to increase the sensitivity
of his reporting. The Committee has concluded that Dr Bottrill was
unaware of the risk his practices posed to patients. Compulsory participation
in a formal course of continuing education and re-assessment of his
competence should have remedied this. For this reason the Committee
has concluded that the absence of any requirement to participate in
continuing education or any formal re-assessment of competency are
factors that are likely to have led to the unacceptable under-reporting
in the Gisborne region.
Conclusion
5.191 The Committee has identified those factors directly
relating to Dr Bottrill’s practice which it considers are likely to
have led to unacceptable under-reporting in the Gisborne region. It
has also identified factors relating to the delivery of cervical cytology
services during the time that Dr Bottrill was in practice and afterwards
which it considers are likely to have led to under-reporting in the
sense that it was the presence of these factors which enabled Dr Bottrill
to practise as he did and which meant that the under-reporting was not
detected sooner. If Dr Bottrill had not been able to practise on his
own, carrying out all the primary screening in circumstances where there
was no internal or external quality control at Gisborne Laboratories,
and where the laboratory was not registered with TELARC or any other
quality control authority, it is unlikely that he would have under-reported
for as long as he did and at such an unacceptable level. An effective,
well-designed and well-implemented programme would have prevented him
from practising in this way. Ultimately, it was the flaws in the National
Cervical Screening Programme that permitted Dr Bottrill to practise
as he did. In August 1990 the Expert Group’s Policy Statement of
the National Cervical Screening Programme recognised that screening
can fail because of poor quality in either the smear taking or smear
reading. The Policy Statement noted that there had been reports
of deficiencies in these aspects of screening in parts of New Zealand.
The Policy Statement went on to emphasise the importance of management
systems in ensuring that poor quality in smear taking or smear reading
did not cause a programme to fail:
"In an organised programme,
the management system can minimise the possibility of such failures
by measuring the technical quality of the screening process and
by monitoring the follow up of women with abnormal smears."
It is unfortunate that the recognition in 1989 of the
importance of a screening programme’s management system did not flow
through to ensure that it was well designed and well implemented.
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