Report of the Ministerial Inquiry into the Under-reporting
of Cervical Smear Abnormalities in the Gisborne Region
5. Term of Reference Two
What are the factors that are likely to have led to the
under-reporting?
5.1 Dr Bottrill was at a loss to explain why so many
of the cervical smear tests read at Gisborne Laboratories had been under-reported.
The only explanation he could offer was that his work performance had
deteriorated after he had undergone heart surgery in July 1990.
5.2 Counsel for the women affected submitted that in
answering Term of Reference Two the Committee should identify both direct
and indirect factors that are likely to have led to under-reporting.
However, Counsel for the Ministry of Health submitted that even if there
were defects in the Programme’s delivery, those defects could not have
led to the under-reporting. The Committee considers that the phrase
" to identify the factors that are likely to have led to that under-reporting"
has a meaning which goes beyond identifying the immediate cause of the
under-reporting. Clearly the immediate cause of any under-reporting
is someone misreading a smear test. By directing the Committee to identify
the factors that are likely to have led to unacceptable under-reporting
the Minister of Health is seeking an answer which may go some way to
explain how the under-reporting came about. This will inform the Minister
of the steps that need to be taken to ensure that unacceptable under-reporting
is avoided in the future. Unless the Minister is made aware of all the
factors without which damage could not have occurred the Minister will
not be best placed to determine the remedial action required. For this
reason the Committee considers that Term of Reference two requires it
to look for all factors which directly or indirectly materially contributed
to the under-reporting.
5.3 In the Committee’s view there are a number of factors
that are likely to have led to the unacceptable level of under-reporting
at Gisborne Laboratories. These factors fall into two groups: those
that relate directly to the practices followed in Gisborne Laboratories
when reading cervical cytology; and those that relate to the delivery
of cytological services in New Zealand between the years 1990 to 1996.
The second group of factors directly influenced how cervical cytology
was carried out in Gisborne Laboratories during this time. Each group
of factors is discussed in turn below.
Factors Relating To Practices Followed In Gisborne
Laboratories
5.4 The factors relating to practices in Gisborne Laboratories
that are likely to have led to under-reporting of cervical smear tests
are:
(i) No specialised division of labour for reading
cervical smear tests;
(ii) Inadequate internal quality control including
no organised correlation of biopsy results with cytology results;
(iii) Inadequate systems and procedures;
(iv) No external quality control;
(v) No accreditation with an independent quality
control authority;
(vi) Dr Bottrill’s inadequate participation in continuing
medical education; and
(vii) No awareness that the laboratory’s practices
put patients at risk.
Each of these factors, their impact on the laboratory’s
performance and the likelihood of them leading to under-reporting is
discussed below.
No Specialised Division Of Labour For Reading Cervical
Smear Tests
5.5 In most laboratories cervical smear tests are screened
by more than one person. The usual practice is for a specially trained
cytotechnologist or cytoscreener to carry out the primary screening.
This entails the careful microscopic examination of slides on which
cellular material from the cervical smear is fixed. It can be a monotonous
repetitive task as the examination of each slide follows a set pattern.
Cytotechnologists and cytoscreeners are trained to look for unusual-looking
cells on the slide as these indicate cellular abnormalities. Their task
is to sort the abnormal from the normal smears. Once the abnormal smears
are identified they are sent to the laboratory pathologist who also
examines them and then categorises the type of cellular abnormality.
5.6 The importance of a specialised division of labour
when reading cervical cytology has been well recognised for some time.
The World Health Organisation issued a Bulletin in 1986 titled Control
of Cancer of the Cervuix Uteri which stated:
"All smears should be processed
and screened at a cytology laboratory in which the following procedures
must be performed: staining, examination by a cytotechnologist,
confirmation by a cytopathologist, communication of results to a clinician
and follow-up of all cases of abnormal cytology. (emphasis added)
In the same passage the need for pathologists and other
laboratory staff to maintain their competency in cervical cytology by
reading a large volume of cervical smear tests and by avoiding working
in isolation was also recognised:
"Cytology services should be
centralised. A large volume of work contributes to the successful
operation of a cytology laboratory because a specialized division
of labour is possible and a large number of abnormal smears representing
various pathologies will help to maintain the cytotechnologists’ skills.
…Usually single unsupervised technicians should not be placed in isolated
areas or health centres, since even well trained screeners will lose
their skills if not exposed to a large number of positive specimens,
teaching and supervision."
5.7 At Gisborne Laboratories there was no specialised
division of labour when it came to reading cervical smear tests. The
cervical cytology was read by one person, and this was usually Dr Bottrill.
He was the only pathologist that Gisborne Laboratories permanently employed.
Of the 22,976 smear tests sent to Douglass Hanly Moir Pathology in Sydney
for re-reading, 20,860 had originally been read by Dr Bottrill. Gisborne
Laboratories received approximately 4000-5000 cervical smear tests per
annum.
5.8 Dr Bottrill carried out all the primary screening
of the smear tests, even though he had no specialist training in cytoscreening.
On the occasions when Dr Bottrill went on leave and a locum was employed
the locum also carried out the entire task. On his return from leave
Dr Bottrill did not check the smear tests which the locum had read.
Occasionally, when the workload became too heavy, Dr Bottrill employed
a locum to assist him. Once again the practice was for Dr Bottrill and
the locum to work separately on an allotted group of slides. Dr Bottrill
said that for the first week he would check the locum’s work by re-reading
the smear tests and the reports; after that the locum was left to do
his allotted work. Dr Bottrill used to rescreen 10% of the negative
smear tests approximately once a week and when a locum was employed
it seems that Dr Bottrill included the smear tests the locum read in
the rescreening exercise. This was the limit of any sharing of the task
of reading cervical smear tests.
5.9 The Committee heard no evidence to support primary
screening of cervical smear tests being performed by a pathologist.
Professor McGoogan, Dr Gabriel Medley and Dr Farnsworth are highly qualified
and experienced cytopathologists. They each informed the Committee that
they considered their skills were not suited to primary screening. In
her evidence to the Committee Professor McGoogan said:
Dr Duggan Question Could I ask you
for your own personal opinion on whether pathologists who have not
been trained in the skills of primary screening should function
as a primary screener?
A I have a very high regard for
the skills of primary screeners, it is an exceptionally difficult
skill to develop and maintain day in day out. It is not a skill
which I have as an individual. I would have to undertake a similar
training and concentrate my training in that area to achieve the
same skills.
Q You, as an acknowledged expert
in cytopathology, do not consider you should function as a primary
screener .....
A Yes, I agree.
5.10 Other pathologists from whom the Committee heard
evidence also did not think it advisable for a pathologist to perform
primary screening. Dr Beer, a pathologist from Tauranga who gave evidence
for the Association of Community Laboratories said he thought it dangerous
for a pathologist to perform primary screening. Dr Teague, who gave
evidence for the Royal College of Pathologists of Australasia said he
did not consider himself competent to primary screen cervical smear
tests and that he would not function as a primary screener. Dr Teague
had organised a review of a small group of Dr Bottrill’s slides for
an accident compensation claim against Dr Bottrill for medical misadventure
due to the under-reporting of a patient’s cervical smear test. When
Dr Teague learnt how Dr Bottrill practised cervical cytology he advised
Dr Bottrill to stop reading smear tests and to send the laboratory’s
cervical cytology elsewhere; Dr Bottrill did not follow Dr Teague’s
advice.
5.11 Dr Bottrill said that he had not wanted to act
as his own primary screener and that he had done so because: between
the years 1990 and 1995 there was a shortage of cytotechnologists; Gisborne
Laboratories did not have enough work to employ a full time screener;
and given the shortage of cytotechnologists it was too difficult to
find someone prepared to do this work part time in a rural area like
Gisborne. An additional reason Dr Bottrill gave for carrying out the
primary screening was that he wished to offer a full service to the
Gisborne region and the alternative to him carrying out the primary
screening was for Gisborne Laboratories to send cervical cytology elsewhere.
5.12 None of the reasons Dr Bottrill gave for the laboratory
following this practice justifies it. There was no question of Dr Bottrill
acting out of necessity. The cervical cytology of women from the Gisborne
region could have been read at a laboratory in another region. All the
cervical cytology from the Gisborne region is now read by laboratories
in other regions. Since Medlab Hamilton purchased Gisborne Laboratories
the cervical cytology that was read by Gisborne Laboratories is read
in Hamilton. The Gisborne hospital laboratory has ceased reading cytology
and sends any cytology it receives elsewhere. When Dr Bottrill was in
practice, but on sick leave the cervical cytology Gisborne Laboratories
received was read in a laboratory in Palmerston North. Between 1990
to 1996 there was no obstacle which prevented Gisborne Laboratories
from sending cervical cytology elsewhere, if it had chosen to do so.
5.13 The practice of working alone that Dr Bottrill
followed meant there was no opportunity for a second pair of eyes to
view the cervical smear tests that he screened. Consequently, unless
he arranged to seek a second opinion on a smear test, there was no likelihood
of any error he made in reading a smear test being picked up. The Committee
heard evidence from more than one pathologist on the risk of this practice
to patients. The best evidence was given by Professor McGoogan:
CHAIR: Question I will start the
scenario again, a small laboratory where you have one pathologist,
no-one else employed full or part time, approximately 5000 smears
per annum coming into the laboratory, the single pathologist doing
all screening primary and then I don't know the format he used to
screen abnormals, but have you got enough in front of you now to
formulate an opinion? .....
A Yes. this is in my experience
a very unusual situation. It is difficult in a situation where there
is only one person for that individual to quality control themselves
and while it is not impossible to maintain quality service under
those circumstances it would be extremely difficult and would require
exceptional measures to be put in place by the individual to ensure
competence and a quality service.
Q Can you describe how it might
be done, in other words, what those quality control measures might
be?
A I can think of ways but what you
are really asking me is if I want to set up a bad service how would
I do it with the least risk to women.
Q You have said it could be done,
so please outline the measures? .....
A There would have to be frequent
and good interaction with pathologists in another laboratory whereby
there was exchange of work between the two laboratories or at least
in one direction from the single handed pathologist laboratory to
the other laboratory for quality control, internal quality control,
there would have to be well documented processes and data collected
for that quality control. Biopsy smear correlation would be imperative
in that situation so that the pathologist knew that patients that
he recommended be referred for colposcopy had been appropriately
referred, in other words, that the majority of these patients did
indeed have disease and that the biopsy reflected the disease he
suspected from his cervical smear report, and that he frequently
participated in external quality assurance, he frequently attended
meetings of cytologists with cytology topics pertaining to cervical
screening, and that he ensured that his laboratory met all external
accreditation procedures and processes that were available, and
even then I think there are major risks involved.
5.14 The risk of error when one person reads all the
cervical cytology was heightened by Dr Bottrill’s practice of cervical
cytology as he did not regularly adopt any of the measures which Professor
McGoogan outlined as essential to overcome the risks of a pathologist
acting on his own:
He had no internal quality control of the type
contemplated by Professor McGoogan;
He did not participate in any external quality
control programme;
Gisborne Laboratories was not accredited with
any independent accreditation authority;
It had no organised programme to correlate
a patient’s abnormal cytology results with the later discovery
of cancerous or pre-cancerous lesions by biopsy;
Dr Bottrill’s contact with other pathologists
and his attempts at continuing education were insufficient to
enable him to overcome the risks inherent in acting as a sole
practitioner in cervical cytology;
When Dr Bottrill was asked about the measures
which Professor McGoogan had outlined as necessary, if a pathologist
were to practise cervical cytology on his own, he was unable
to inform the Committee if his practices met these measures.
5.15 Dr Teague’s view of Dr Bottrill’s practice was
similar to that of Professor McGoogan. He described the practice as
suboptimal:
"Q Would you describe it as
an acceptable practice?
A I think it would be sub-optimal
the way it was done.
Q And why is that?
A Particularly for the reason that
there was only one person doing essentially both the primary and
secondary screening or rechecking. There was some evidence I believe
that Dr Bottrill did rescreen 10% of slides and there are statistics
which show in fact that if the same person rescreens a slide they
may get a different answer so to that extent there will be some
benefit from that, but I believe that it would not be the benefit
that one would expect to from getting a different pair of eyes to
look at it."
5.16 The Committee accepts the views that these witnesses
have expressed about Dr Bottrill’s practice. It agrees with the view
expressed by Professor McGoogan that a laboratory that employs one person
to carry out this task is providing a bad service. It considers that
the somewhat subjective nature of the task of reading cervical cytology
makes it too risky for one person to carry out, as misread smears are
less likely to be discovered. The Committee considers that the practice
followed at Gisborne Laboratories of having one person read the cervical
cytology is a factor that is likely to have led to the unacceptable
level of under-reporting that occurred at the laboratory.
Inadequate Internal Quality Control
5.17 In his evidence Dr Bottrill expressed the view
that quality control was something which played a greater role in large
laboratories and he saw no need for it in a small laboratory like Gisborne
Laboratories. The internal quality control that he employed consisted
of him, approximately once a week, re-reading 10% of the smear tests
that he had originally read as normal. He neither documented this exercise,
nor did he compare the re-read results with the original results. He
could not recall any occasion on which, when carrying out a random re-reading
of slides, he had discovered a smear test which he had originally read
as normal and which on rereading he found to be abnormal. Nor could
he remember a time when, on re-reading a slide, he became concerned
about his original report. Considering the number of under-reported
smear tests that have now come to light it seems surprising that the
10% random re-screening he carried out did not reveal any of these errors.
The Committee can only conclude that Dr Bottrill had "calibrated"
his eyes to read smear tests with a very high specificity and that on
any second view of a smear test he was only corroborating his original
error.
5.18 Apart from the 10% random re-screening there was
little else done in the way of internal quality control. In 1993 when
Gisborne Laboratories had applied for TELARC accreditation, work began
on a quality control manual; however, this work cannot have been taken
very far, or if it was it cannot have been effective as Medlab Hamilton
found it necessary to replace it with its own quality control manual
when it assumed control of Gisborne Laboratories.
5.19 Gisborne Laboratories had no organised programme
for correlating biopsy results with cytology results. Dr Bottrill’s
evidence was that he did keep records of cytology/ histology correlation
on the occasions when the histology was sent to him for diagnosis. However,
he accepted that where the biopsy was performed at the local hospital
he was unlikely to receive information about the histology result. There
was no formal communication between Gisborne Laboratories and the local
hospital which would have provided him with this information. If Dr
Bottrill had been able to conduct an organised programme correlating
histology with cytology this would have informed him of the accuracy
of his reading. It may have brought to his attention his false positive
rate and true positive rate which the Committee knows to have been too
low. Had Dr Bottrill realised his false positive rate was extremely
low that may have made him alive to the probability that he was "setting
the bar too high" and consequently under-reporting too many smear
tests. Had he realised his true positive rate was too low he would have
known that he was failing to recognise abnormal smear tests and reporting
them incorrectly as normal (false negatives). A programme of looking
back at a woman’s previous negative smear tests when she was found to
have a high-grade abnormality on histology to determine if those smear
tests were false negatives should have alerted Dr Bottrill to his under-reporting.
In the circumstances the Committee’s view is that at Gisborne Laboratories
correlation of histology with cytology occurred sporadically and was
not sufficient to produce the quality control benefits which come from
an organised programme of histology cytology correlation.
5.20 In the Committee’s view the internal quality control
followed at Gisborne Laboratories was inadequate. It did not meet the
expectations of internal quality control that Professor McGoogan outlined
in her evidence. Her expectations of internal quality control are consistent
with those of International Accreditation New Zealand (IANZ), the national
accreditation authority for quality assurance, laboratory testing and
industrial design. The Committee heard evidence from Mr Graham Walker
the former programme manager medical testing and radiology of IANZ on
the parameters of internal quality control. In Mr Walker’s view Dr Bottrill’s
internal quality control fell outside these parameters.
5.21 Mr Walker visited Gisborne Laboratories in 1993
when it had applied to the Testing Laboratory Registration Council (TELARC),
which formerly carried out IANZ’s functions, for accreditation. The
application did not proceed. During his visit Mr Walker noted the absence
of documented laboratory procedures and recorded that this was something
which Gisborne Laboratories would have to institute if it were to become
accredited. An additional aspect of internal quality control that IANZ
considered significant, and which was lacking at Gisborne Laboratories
was the ability to have a smear test checked by a second person. In
his brief of evidence to the Committee Mr Walker said:
"An important aspect of internal
quality control is the ability to release apparently normal slides
on the basis that a second person within the laboratory has re-screened
a proportion of those slides and validated the test results. Gisborne
Laboratories did not have such a second person. There was, therefore,
no internal quality check, as well as there not being any opportunity
for Dr Bottrill in the cytology/histology context to exchange ideas
with another cytopathologist. In such a circumstance there is extreme
pressure on the pathologist to get the test result right as there
are no other means to intercept problems and carry out frequent
and random checks on test results".
5.22 The Committee considers that the lack of adequate
internal quality control at Gisborne Laboratories is a factor that is
likely to have led to the unacceptable level of under-reporting that
occurred at the laboratory. Had the practices at Gisborne Laboratories
conformed with the internal quality control requirements outlined above
it is likely that the level of under-reporting which occurred would
have been detected sooner or perhaps avoided altogether.
Inadequate Systems And Procedures
5.23 Dr Bottrill’s views on quality control being more
suited to big laboratories may have coloured his opinion on the usefulness
to a small laboratory of organised systems and procedures in general.
The laboratory systems he followed had shortcomings: he had no procedure
in place to prevent a slide mix up, although there is no evidence this
had ever happened; he did not as a matter of routine carry out "look
back" exercises of a woman patient’s previous smear tests; he had
no system to inform him as to whether or not he had read a woman patient’s
previous smear tests, (this meant that unless he was told by the woman’s
smear taker that he had read her previous smear tests he had no way
of knowing whether or not there were previous smear tests to look back
on); he did not regularly get information about his female patients
from the National Cervical Screening Register.
5.24 The deficiencies in the systems and procedures
at Gisborne Laboratories would not have promoted a competent performance
in cervical cytology. The Committee considers that this is a factor
which, if not of itself, then certainly combined with the other factors
listed herein is likely to have led to the unacceptable level of under-reporting
that occurred at the laboratory.
No External Quality Control
5.25 Gisborne Laboratories did not participate in any
external quality assurance programme. Dr Bottrill did not appear to
place a high value on quality control. In his evidence to the Committee
he said:
Q Was it your view at the time that
measures such as external quality assurance and quality control
systems played no part in affecting your standard of smear reading?
A Yes
Q So you didn’t think they would
help your accuracy, is that right?
A I think that is correct, yes
Dr Bottrill said that he liased with a series of pathologists
who were employed at Gisborne Hospital. He said he visited the hospital
four or five times a week around lunchtime to have a general discussion
with the current hospital pathologist and to show him or her any slides
of interest or difficulty. He said that he maintained good collegial
relationships by doing this and he was also able to obtain second opinions
on difficult or interesting slides. However, he accepted that there
was not always a pathologist employed at the hospital, that there could
be periods of up to one year when nobody was there and that at those
times he was the only pathologist in Gisborne. The Committee considers
that the informal interaction Dr Bottrill had with the pathologists
at Gisborne Hospital was insufficient to remove or reduce the risk inherent
in practising as he did. It comes nowhere near the type of interactions
that are carried out for the purpose of external quality control.
5.26 Although the evidence shows that in 1991 there
was no entirely satisfactory external quality assurance programme available,
and it seems that was still so in 1993, the Royal College of Pathologists
of Australasia offered a programme which was a step in the right direction
and over the years this programme has developed and improved. The Committee’s
view is that participation in an external quality assurance programme
which is still in the early stages of development and which may not
be entirely satisfactory has benefit nevertheless, as it should make
a pathologist more alert to the possibility of error, and it should
cause a pathologist to focus more on the need to adopt measures to reduce
the risk of error occurring. The external quality assurance programme
which the Royal College of Pathologists of Australasia offered involved
a pathologist receiving slides from the College, reading them and reporting
the results to a central collating agency and subsequently receiving
reports which compared the reports of his or her slide reading with
the consensus view of the other pathologists who participated in the
programme. In this way a pathologist was able to learn whether or not
his or her reading of slides was within the average range or above or
below that range.
5.27 Participation in such a scheme may have alerted
Dr Bottrill to the likelihood that he was failing to recognise some
abnormal smears and consequently he was under-reporting the abnormalities
he was seeing. The Committee considers that the failure at Gisborne
Laboratories to ensure that the pathologist participated in an external
quality control programme is a factor that is likely to have led to
the unacceptable level of under-reporting that occurred at the laboratory.
No Accreditation With An Independent Quality Control
Authority
5.28 Throughout the time that Dr Bottrill was in practice
Gisborne Laboratories was not accredited with an independent laboratory
quality control authority such as TELARC. Even though the requirements
for TELARC accreditation were not as demanding in the early 1990s as
they are now, they still would have deterred Dr Bottrill from practising
as he did. Most importantly, from 1993 onwards, it seems that so long
as Gisborne Laboratories employed only one person to carry out all the
cervical cytology it would have been denied accreditation. Mr Walker
said in evidence:
Chair Question You have talked …
about the situation of Dr Bottrill doing all the cytoscreening on
his own, in terms of TELARC IANZ accreditation again looking at
it from 1993 to 1996, would TELARC accredit a laboratory where a
single pathologist was doing all the cytoscreening.
A Very definitely not. I have already
indicated …those three laboratories where their cytology accreditation
has been suspended, it is as a result of the loss of their last
cytotechnologist. So that a single pathologist however competent
would not meet our requirements of accreditation.
Q So … one of the things that Dr
Bottrill would have had to have done if he wanted to obtain accreditation
for the laboratory was to hire a cytoscreener to work with him.
A Or to make arrangements for another
pathologist to rescreen his work.
Q Yes.
PROFESSOR DUGGAN INTERJECTS
PROFESSOR DUGGAN: By that comment
Mr Walker, it is acceptable to TELARC that gynaecological slides
can be screened by a pathologist?
A Solely …by a single pathologist,
no.
Q Well no, screened by a single
pathologist with the quality control done by another pathologist.
A We would have considered that
as an option. It would have been unusual.…
A I don’t know of a pathologist
in New Zealand at the present point in time that would have absolute
confidence in his or her work without somebody else having reviewed
a good percentage of it, that someone else could equally be another
pathologist or a cytotechnologist.
5.29 In addition to ensuring that more than one qualified
person was involved in cervical cytology TELARC accreditation would
have led to improved systems and procedures at Gisborne Laboratories.
By May 1991 TELARC had issued recommendations, which had been formulated
by the Cytology Advisory Liaison Committee, and which TELARC intended
its assessors to discuss with laboratories during accreditation assessments
for cytology. These recommendations were not extensive, however, they
required:
a recommended process for checking abnormal
smear tests;
random rescreening of 10% of negative smear
tests;
they identified maximum annual and daily limits
for reading smear tests;
they encouraged participation in an external
quality control programme; and
they recommended the phasing out of off-site
(home screened) smear tests.
5.30 By June 1991 TELARC had issued the New Zealand
Code of Laboratory Management Practice. This document, which was produced
to the Committee as exhibit BJL/MEDH/5, set out requirements for laboratory
practice. These included having in place laboratory quality control
procedures; the purpose of which is to demonstrate that accurate and
reliable tests are being produced, to anticipate potential sources of
error in a laboratory’s operations and to implement checks at appropriate
control points to detect any errors that should occur.
5.31 Furthermore, from 1991 TELARC recommended that
laboratories accredited for cytology participate in an external quality
assurance programme. By 1993 participation in an external quality control
programme had become "virtually essential" for TELARC accreditation.
When asked to explain what "virtually essential" meant Mr
Walker described it as indicating a requirement which an assessment
team might impose on a laboratory. And although it was not an absolute
requirement in 1993 it was about to become so within a short period
of time, so that any laboratory which did not participate in an external
quality control programme in 1993 and which wanted accreditation would
have had to enrol in such a programme in the very near future if it
wanted to obtain or retain its accreditation. Mr Walker told the Committee
:
A Historically, in the absence of
an appropriate programme of inter-laboratory comparison, the requirement
of IANZ, TELARC in those days, for mandatory participation, was
not in existence but as those programmes became more and more developed
and more and more accepted by the industries participating in them,
they became progressively more likely to become requirements of
accreditation, the error that we are talking about here was at the
point where it was virtually a requirement, a few years before that
it would not have been a requirement and very soon after that it
became a mandatory requirement.
Q … so when you say virtually essential
you are meaning that this is something that in a very short period
of time is going to become essential and so you are signalling that
to the reader of the letter.
A That’s a very fair assessment
of what I intended to say, perhaps I should have used those sorts
of words.
Q And so your expectation would
be then that the reader takes that phrase at their peril and either
does something about it immediately or waits until it becomes an
absolute requirement and that that will happen very soon.
A I have every confidence that had
Gisborne laboratory taken the next step and been initially assessed,
that the peer assessment team would have required participation
in that programme and that was my intent and perhaps using the words
virtually essential doesn’t appropriately convey that intent.
5.32 Accreditation does not guarantee that laboratories
will not under-report an unacceptable number of smear tests. It focuses
on the systems and procedures a laboratory uses to achieve its results
and not on the substance of the results. What it does is set in place
systems and procedures to ensure that a laboratory has appropriately
trained staff, well maintained equipment and recognised methods and
procedures in place. However, if these systems and procedures are properly
followed they should enhance a laboratory’s performance substantively
as well as procedurally as they are likely to lead to good quality results
and to reduce the opportunities for error.
5.33 Accreditation also creates a culture and an awareness
of quality assurance and the benefits to be derived from it. A laboratory
which is attuned to the need for quality assurance to improve work performance
is less likely to produce errors in smear test reporting than a laboratory
where the need for quality assurance is unrecognised. Moreover, the
process of obtaining accreditation involves subjecting a laboratory
to a full review by a team of experts in the field for which accreditation
is sought and thereafter regular inspections. This degree of attention
would be likely to bring any risk associated with a laboratory’s performance
to notice.
5.34 Had Gisborne Laboratories been accredited with
TELARC by the end of 1991 the impact of the CALC inspired recommendations
and the New Zealand Code of Laboratory Management Practice combined
with the employment of a second person to share the reading of cervical
cytology would have improved the systems and the procedures Dr Bottrill
followed and this in turn is likely to have reduced his under-reporting
to a more acceptable level. Certainly by 1993 accreditation with TELARC
would have resulted in improved systems and procedures including the
introduction of internal and external quality control and a requirement
to share the task of reading cervical cytology with another person.
It would have brought to an end the practices that the Committee considers
are likely to have led to the unacceptable level of under-reporting.
The Committee, therefore, considers that the laboratory not being accredited
is a factor that is likely to have led to an unacceptable level of under-reporting.
Inadequate Participation In Continuing Medical Education
5.35 Dr Bottrill’s specialist training was in anatomical
pathology. He was appropriately trained in cytopathology given the standards
of the time during which he trained, however at that time cytopathology
was in its infancy. Since then, cytopathology has evolved and grown,
and the practice has become more specialised. Dr Bottrill informed the
Committee that he had no specialist qualification in cytology; the examination
he sat in the early 1970s to become a member of the College of Pathologists
of Australia had no cytology component. Dr Bottrill’s qualifications
and experience can be contrasted with recommendations contained in standards
the Cervical Screening Liaison Advisory Committee (CSLAC) sent to TELARC
in 1995. These standards reveal how the perceived need for pathologists
to have training in cytology had increased. They contain a recommendation
that pathologists wishing to practise in cytopathology should have a
minimum of two years special supervised training. Those pathologists
who have the qualifications in anatomical pathology but who lack expertise
in cytopathology are advised to undertake appropriate training prior
to taking responsibility for cytological reporting in New Zealand laboratories.
5.36 Competence in a changing field is maintained by
undergoing additional formal training in an accredited training centre
and/or through participation in continuing medical education activities.
Dr Bottrill did not undergo additional training. Dr Bottrill’s
evidence was that he continued his medical education by: attending approximately
six to eight local post graduate meetings per year; biannual attendances
at conferences and workshops relating to cytology and histology; attending
the cytology sessions of the Royal College of Pathologists of Australasia
between the years 1968 to 1993; attending a conference in Mexico of
the World Association Society of Pathology in 1993 and a conference
by the same organisation in Auckland in 1995; and attending the New
Zealand Society of Cytology meetings on numerous occasions, the last
being in 1992. He also spent time reading in the library at Gisborne
Hospital. It seems from the evidence the Committee heard that Dr Bottrill’s
participation in continuing education began to decline in 1993. Furthermore,
his participation at the conferences and workshops he did attend does
not appear to have made him realise or gain any insight into the risk
he was taking by practising as a sole practitioner in cervical cytology,
nor did it improve his reading of cervical smear tests.
5.37 The Committee considers that the degree to which
Dr Bottrill participated in medical conferences and workshops in the
period from 1990 to 1996 was insufficient for him to improve his cytopathology
practices. He could have done so by additional formal training, however
he never underwent such training. In the Committee’s view more focussed
continuing medical education and additional formal training in cytopathology
would have brought home to Dr Bottrill the danger inherent in the practices
followed at Gisborne Laboratories, and the need to reform the laboratory’s
practices. For this reason the Committee considers that the failure
of Dr Bottrill to participate in continuing medical education is a factor
that is likely to have led to the unacceptable level of under-reporting
that occurred.
Lack Of Awareness And Insight As To How The Laboratory’s
Practices Put Patients At Risk.
5.38 The Committee considers that another feature of
the practice of cervical cytology in Gisborne Laboratories, which was
not compatible with the effective or safe delivery of cervical cytology,
was that Dr Bottrill had no awareness of or insight into the extent
to which the laboratory’s practices put patients at risk. In his evidence
to the Committee he said:
"I think if I were doing it
again I wouldn’t make any major changes. I was completely unaware
at the time that I retired that there was a problem".
5.39 This lack of awareness and insight as regards the
risk inherent in his practice of cervical cytology probably explains why
Dr Bottrill continued to read cervical cytology on his own until his retirement
in March 1996, and why he failed to have in place any measures to reduce
the risk of practising in this way. Dr Bottrill’s view on his practice
at Gisborne Laboratories is completely at odds with the evidence the Committee
has heard from experts on how a laboratory should carry out cervical smear
test screening and the inherent dangers when carried out by a sole practitioner.
He refused to accept that the following features of his practice contributed
to his under-reporting:
his lack of expertise in cytopathology and primary
screening;
his lack of appropriate continuing education;
the laboratory’s failure to take timely steps to
get accredited;
the laboratory’s failure to institute appropriate
internal and external quality control;
the laboratory’s failure to institute a system of
peer review; and
the laboratory’s failure to have systematic look-back
procedure for patients.
This attitude of Dr Bottrill only confirms for the Committee
his unawareness of and lack of insight into the risks his practice posed
to patients.
Factors Relating To The Delivery Of Cytological Services
In New Zealand Between 1990 And March 1996
5.40 From the years 1990 to 1996 cytological services
in New Zealand were delivered in circumstances where:
Laboratories reading cervical cytology were not required
to follow quality control processes or to be accredited with an independent
quality control authority;
The Government Policy for National Cervical Screening
(1991) and the 1993 updated version in relation to laboratories
reading cervical cytology were not well designed;
The National Cervical Screening Register was not
functioning optimally;
There were no performance standards for laboratories,
and there were no reliable data on laboratories’ performance;
There was no monitoring and evaluation of the performance
of laboratories reading cervical cytology;
The health authorities did not take heed of the warnings
provided by the failures of screening programmes in other countries;
There was a failure to ensure all components of the
programme where in place from an early stage.
All of this is indicative of a failure to design and
deliver a soundly based cervical screening programme. The Committee
has already identified the factors relating to the practice of cytology
at Gisborne Laboratories that it considers are likely to have led to
the unacceptable level of under-reporting that occurred at that laboratory.
The Committee considers that but for the failure to deliver a soundly
based cervical screening programme the cytology practices at Gisborne
Laboratories could not have continued for as long as they did. If the
factors, which the Committee considers the Programme lacked, had been
operative the practice of cervical cytology at Gisborne Laboratories
would have been improved or come to an end. Either way the risk of unacceptable
under-reporting would have been considerably reduced. Thus the Committee
considers that the failure to deliver a soundly based cervical screening
programme is a factor that is likely to have led to the unacceptable
under-reporting that occurred in the Gisborne region. The Committee’s
reasons for reaching this view are set out below.
No Compulsory Quality Control
5.41 Compulsory quality control including accreditation
for all laboratories reading cervical cytology was not introduced until
some time in late 1996. It is difficult to be precise about when these
requirements were introduced as their introduction into individual laboratories
was achieved at different times and through more than one mechanism.
What is clear is that before this time quality control (and accreditation)
was not mandatory, even though the need for quality control of laboratories
reading cervical cytology for a cervical screening programme was seen
as essential by more than one authoritative source from as early as
the mid- nineteen eighties. A review of some of the authoritative material
is set out below.
5.42 The 1986 Bulletin of the World Health Organisation
on Control of Cancer of the Cervix Uteri recognised the need
for quality control to reduce the occurrence of false negative reports.
It said:
" Quality control systems must
be developed in cytology laboratories to keep the number of
false negatives reports as low as possible." (Emphasis added)
5.43 In 1988 a Department of Health publication titled
Towards a More Effective Cervical Screening Service for Women recognised
the need to develop quality control measures in laboratories reading
cervical cytology. It said that:
" A review of laboratory services
for cervical cytology is required. This review will need to include
the development of quality control measures to ensure that cytological
services in laboratories maintain a consistently high standard."
In its submission to the Committee the Ministry of
Health said that this publication demonstrated that the Department of
Health was "well aware of the issues surrounding quality relating
to a national [screening] programme, including the key issues surrounding
quality in laboratories."
5.44 In November 1989 the Report Of The Ministerial
Review Committee On Implementation Of A Government Policy for National
Cervical Screening was published. Section 8 of the report covered
smear readers and standards of competency. It began by noting that:"
Laboratories and their staff will play a key role in the success of
any cervical screening programme, as it is principally through them
that cytological information will be collected and recall dates established."
Sections 8.10-8.13 set out the importance of quality controls to ensure
consistency in the reporting of cervical smears.
5.45 In July 1990 Dr Judith Straton of Division of
Public Health University of Western Australia was engaged by the Department
of Health to review of the National Cervical Screening Programme. She
produced a document titled Review of the Government Policy for National
Cervical Screening in which review she wrote:
"Aspects of the laboratory
services which need attention include accreditation and quality
control. …It seems that the accreditation
of laboratories by the national laboratory accreditation organisation
(TELARC) is on a voluntary basis and only a relatively small number
of laboratories are accredited. I have not seen the criteria for
accreditation used by TELARC but I understand that they do not at
present cover all the necessary areas. I believe that there should
be a system of accreditation of laboratories carrying out cervical
cytology screening, which is tied to the reimbursement of laboratories
for reading smears. Public hospital laboratories should also be
included." (emphasis added)
5.46 In August 1990 an experts groups which had been
established in December 1989 to advise the Minister of Health on national
policy and resource allocation for the National Cervical Screening Programme
presented a report titled Policy Statement Of The Government Policy
for National Cervical Screening Expert Group. Section 12 of the
report dealt with laboratories. The report acknowledged that: "The
efficiency of the cervical screening programme will depend on high standards
of smear reading by laboratory technicians and an acceptable turn-around
time for reporting on smears. " In section 12.2 the report set
out a proposed implementation strategy for the programme in relation
to laboratories. This provided:
"Section 12.2.2 The expert group
recommends that by 1991 all cytology laboratories serving the National
Cervical Screening Programme should have applied for registration
with the testing Laboratory Registration Council of New Zealand
(TELARC) and should be TELARC registered by December 1993. The only
exceptions will be if TELARC itself is unable to meet these deadlines
or if a laboratory is newly set up, necessitating a reasonable period
of time in which to obtain TELARC registration.
12.2.3 The Department of Health should
be responsible for confirming that those laboratories carrying out
cytology screening for the National Cervical Screening Programme meet
the recommendations set out in 12.2.2. Such confirmation should become
a requirement for receiving the laboratory benefit for reading National
Cervical Screening Programme smears.
12.2.4 The criteria for registration
by TELARC should be negotiated with TELARC by CALC and the Department
of Health. The criteria will include guidelines on :
The reading of a minimum number
of smears a year;
The employment of adequate numbers
of suitably qualified staff;
The maximum workload for each
cytoscreener;
Adequate in-service education;
A satisfactory participation of
both internal and external quality assurance procedures;
Co-operation in providing cytology
reports to the cytology register.
12.2.5 The Department of Health, CALC,
TELARC and other relevant organisations will seek standards for the
training of cytology laboratory assistants. The Department of Health
is responsible for ensuring that there are sufficient training facilities
to meet the cytology screening workforce requirements of the National
Cervical Screening Programme.
12.2.5 Developing a mechanism for
linking the histology results of cervical tissue submitted to laboratories
for diagnosis to the cytology register is an urgent priority for the
Department of Health. The register will also be developed so that
laboratory staff have direct access to a woman’s previous smear history
when reading smears.
5.47 In July 1991 a report was published in the New
Zealand Medical Journal titled Cancer Screening 1991 Cervical Screening
Recommendations: A Working Group Report. The report commented on
the need for quality control of all aspects of cervical screening including
laboratory performance:
" Quality control of all
aspects of cervical screening should be a major emphasis of the
National Cervical Screening Programme. To provide proper quality
control there should be formal evaluation of all the components
of the screening process from recruitment and recall of women to
management of women with abnormal smears. A national register is
the essential management tool to allow this and should be expanded
to include the relevant histology results ensuring correlation and
evaluation of cytology findings. Health educators, smear takers,
laboratory staff, computer staff, colposcopists and therapists should
all be appropriately trained and qualified. Laboratories and
sites for therapy should be accredited . Legislation is essential
to allow all laboratories to provide both cytology and histology
results to the register."(emphasis added)
5.48 In 1991 the Government Policy For National
Cervical Screening (1991) was issued. This was the first written
policy for the Programme. It was prepared by the Department of Health
and approved by the Associate Minister of Health. The Policy was
based on the recommendations that were made in the August 1990 report
of the Expert Group. Part 4 of the Policy defined the role of
laboratories in the implementation of the Programme and the expectations
of their performance in this role. Part 4 incorporated most of the recommendations,
for quality control of laboratories, that appear in section 12 of the
Expert Group’s report. It anticipated laboratories being accredited
with TELARC or a similar authority by 1993; and it described the criteria
for accreditation. This included: having a set minimum number of smears
for reading each year; employing adequate numbers of suitably qualified
staff; having maximum workloads for each cytoscreener; making provision
for adequate in-service education; participating in internal and external
quality assurance procedures and providing cytology reports to the cytology
register.
5.49 It seems that pathologists were not in general
resistant to compulsory accreditation. The minutes of a meeting of the
Cervical Screening Advisory Committee held on 12 December 1991
record the committee’s discussion on how to enforce accreditation of
laboratories. Dr Clinton Teague, pathologist, is recorded as saying
that he did not think that accreditation would be a big problem as most
laboratories were moving towards accreditation, and that compulsory
accreditation had been accepted by laboratories as they had had sufficient
time to gain accreditation. He is also recorded as referring to the
Australian position where laboratories had to be accredited to claim
Medicare subsidies. The Committee has not seen any material or heard
any evidence in the course of its inquiries that would suggest that
pathologists would have strongly resisted the introduction of compulsory
accreditation by making receipt of government funding conditional on
accreditation.
5.50 In 1992 the World Health Organisation published
the Cervical Cancer Screening Programmes’ Managerial Guidelines. In
discussing technical resources for cytological examination the guidelines
state :
"Before a screening programme
is started the resources must be in place for taking the smears
and a cytology laboratory must be accessible to examine and report
on the smears. To ensure that the laboratory services are both efficient
and cost effective they should be centralised, each laboratory being
supervised by a fulltime cytolopathologist with an organised
system of quality assurance and continuous education of cytotechnologists.
(emphasis added)
Later in the Guidelines there is a reference
to an earlier World Heath Organisation publication of 1988 dealing with
laboratories in which it was recorded that: " The laboratory must
have adequate quality control procedures in place for cervical cytology."
5.51 All of the above shows that at an early stage
in the development of the Nation Cervical Screening Programme there
was authoritative material from international and national sources on
the importance of quality control in laboratories reading cervical cytology
for screening programmes. The various reports to the Minister and the
Department on the establishment of a cervical screening programme all
recognised the importance of quality control. Furthermore, the inclusion
of quality control provisions in the Policy in 1991 shows that
by then the Minister and the Department had accepted quality control
was important. Moreover, the Committee was not referred to any material
which suggested that the use of quality control processes in laboratories
reading cervical cytology was unnecessary.
5.52 The Committee’s view was confirmed by the evidence
of Professor McGoogan. She was critical of the failure to have quality
controls in place from the outset. She was shown a flow diagram that
was appended to the draft report of the National Cervical Screening
Workshop of 1988. This flow diagram recorded the points in the Programme
at which quality control and evaluation needed to occur. Professor McGoogan
considered the diagram was a good starting point for implementing quality
control, but that it did not go far enough. When asked to give her opinion
on the Programme’s failure to adopt the diagram of quality controls
and its lack of any quality controls on laboratory performance up to
1996 her response was:
" I would be extremely disappointed
because by the time the New Zealand Programme was implemented
the need for quality control and evaluation for a screening programme
of any kind was well recognised.
Professor McGoogan considered that if quality controls
were not in place from the outset that they should have been in place
by the end of the first cycle of the programme, that is: three years
after its commencement and for good data to be collected from that time
onwards.
5.53 It seems to the Committee that the necessity of
quality control processes for reading cervical smear tests for a screening
programme is incontestable. This is not an idea that has only recently
become accepted. The literature to support this view has been available
for many years and certainly some of it pre-dates the National Cervical
Screening Programme. Furthermore the logic of the necessity for quality
control is readily apparent. One significant difference between laboratory
diagnostic testing for a screening programme and laboratory diagnostic
testing to discover a suspected ailment is that in the latter case the
patient is unwell and presents with signs and symptoms. Because the
patient is unwell there is bound to be further investigation, if the
laboratory misdiagnoses the test, and this should ultimately lead to
the correct diagnosis. None of this applies to a screening programme.
A screening programme involves large numbers of healthy women. The whole
purpose of a screening programme is to detect pre-cancerous abnormalities,
which are generally asymptomatic. This means that a woman who is referred
for a cervical smear test will usually not be displaying any signs.
If her smear test is misdiagnosed there is nothing to alert her or her
medical practitioner to that possibility. It, therefore, seems obvious
to the Committee that there are, and always have been, more pressing
reasons for having quality control processes in laboratories reading
cervical cytology for screening programmes than in respect of other
diagnostic services. So that, even though during the period under review
general laboratory services were not subject to compulsory quality control
or accreditation requirements, there was good reason to treat cervical
cytology differently. Compulsory quality control and accreditation of
laboratories reading cervical cytology should have formed part of the
National Cervical Screening Programme from the outset. The Committee
understands that some laboratories could not have become accredited
immediately. However, those laboratories could have been accommodated
by specifying a lead-in period with a definite expiry date after which
only accredited laboratories would be eligible to receive funding for
reading cervical cytology.
5.54 In 1993 the Policy was updated to accommodate
the structural changes in the health sector. Part 4.1.2 which set out
the expectation that laboratories would gain TELARC accreditation by
1993 was amended by removing the indirect reference to this date and
replacing it with an expectation that accreditation should be achieved
within a reasonable period of time. This weaker statement placed less
pressure on laboratories than the earlier expectation, which at least
attempted to place a time limit on the move towards accreditation. At
the same time in 1993 the European Community had issued guidelines on
cervical screening which recognised the importance of quality control
in laboratories. Section 7 of the European Guidelines For Quality
Assurance In Cervical Cancer Screening, which covers quality
assurance in the cytology laboratory, stated:
"Quality assurance in cervical
cytology is designed to achieve an acceptable reliability and consistency
in the results produced in the cytology laboratory."
Then after defining the terms "internal quality
assurance" and "external quality assurance" the Guidelines
continued: "We consider that both schemes are essential for
sound laboratory practice "(emphasis added). The Guidelines
also recognised the need for accreditation of laboratories with an independent
quality control agency:
"Accreditation is assessment
of standards by a panel of experts. The assessment will entail a
visit to the laboratory to inspect working conditions and assess
working practises such as staff workload ratio, quality assurance
measures, health and safety preconditions, arrangements for staff
training, quality of record keeping, arrangements for follow up
of abnormal smears etc"
5.55 It was not until late 1996 that compulsory accreditation
for cervical cytology was imposed; and then it occurred in a piecemeal
fashion as each of the four Regional Health Authorities was able to
conclude a contract (including compulsory accreditation) with the diagnostic
laboratories which provided it with services. In the case of the Gisborne
region the service contract between Midland Regional Health Authority
and Gisborne Laboratories, was not executed until March 1997. This was
nine years after the Department of Health had first recognised the need
to develop quality control measures to ensure laboratories reading cervical
cytology maintained a high standard.
5.56 The Ministry of Health has submitted to the Committee
that there are good reasons why it took so long to introduce compulsory
quality control through requiring laboratories to be accredited with
IANZ or a similar body. These reasons and the Committee’s views on them
are dealt with in the discussion on Term of Reference Three, which looks
at systemic problems with the National Cervical Screening Programme.
For the purpose of answering Term of Reference Two the Committee considers
that it is necessary only to report on those factors that it considers
are likely to have led to under-reporting. The Committee has already
described the benefits of quality control and laboratory accreditation
and the effect they would have had on the practice of cervical cytology
at Gisborne Laboratories. Because it considers that compulsory quality
control (either through TELARC accreditation or a scheme with similar
features which the Department imposed directly as a condition of payment)
would have prevented Gisborne Laboratories from continuing to practise
as it did, the Committee has concluded that the failure to make quality
control and laboratory accreditation compulsory by 1993, at the latest,
is a factor that is likely to have led to the under-reporting in the
Gisborne region, 1993 being the chosen year in the 1991 Policy
for laboratories to have gained accreditation. The Committee is aware
that mistakes can still occur in accredited laboratories, and that accreditation
is not a complete answer to avoiding laboratory errors. In this case,
however, accreditation would have stopped those practices at Gisborne
Laboratories that led to unacceptable under-reporting.
Design Faults Of The Government Policy For National
Cervical Screening (1991) As It Related To Laboratories Reading Cervical
Cytology
5.57 The laboratory component of the 1991 Policy
and the updated 1993 version was set out in clause 4 of both
documents. It was much the same as the recommendations for laboratories
reading cervical cytology in section 12 of the Expert Group’s report
of 1990. Clause 4 provided
"4.1.2 All cytology laboratories servicing the
National Cervical Screening Programme should be registered with the
Testing Laboratory Registration Council of New Zealand (TELARC)
or other recognised authority. It expected that laboratories not so
registered will apply and gain such registration. A reasonable period
of time will be allowed for laboratories to obtain registration. This
may take up to two years.
4.1.3 The Department of Health will be responsible
for confirming that those laboratories carrying out cytology screenings
for the National Cervical Screening Programme meet the requirements
set out in 4.1.4.
4.1.4 The criteria for registration
by TELARC or other recognised authority will be established by the
cytology advisory liaison committee. The Department of Health will
be consulted. The criteria will include :
Reading of a minimum number of smears
a year;
Employment of adequate numbers of
suitably qualified staff;
Maximum workload for each cytoscreener;
Adequate in-service education;
Satisfactory participation in both
internal and external quality assurance procedures;
Provision of cytology reports to
the cytology register.
4.1.5 The Department of Health, the
Cytology Advisory Liaison Committee, TELARC and other relevant organisations
will monitor standards for the training of cytology laboratory assistants."
5.58 The Committee has already discussed in the preceding
paragraphs the importance of quality control, including laboratory accreditation.
Here, the focus of the Committee’s interest is on the special accreditation
for laboratories reading cervical cytology that was planned in clause
4 of the Government National Cervical Screening Policies issued
in 1991 and 1993. The clause specified a number of criteria for inclusion
in TELARC’s general criteria for accreditation. These were additional
criteria which the Policy intended the Cytology Advisory Liaison
Committee (CALC) to develop in consultation with the Department and then
for TELARC to apply them when it came to accreditation of laboratories
reading cervical cytology. Clause 4 demonstrates the Policy’s intent
to shape the criteria for TELARC accreditation for laboratories reading
cervical cytology to include requirements which had been recognised overseas
as being beneficial to the success of a screening programme. Three paragraphs
of clause 4 are significant; these are:4.1.2; 4.1.3 and 4.1.4
5.59 Though the inclusion of clause 4 demonstrates that
the Minister and the Department recognised the importance of quality control
for laboratories, and that the intent of the Policy was for laboratories
servicing the Programme to be accredited with an independent quality control
authority, the poor design of the Policy did nothing to guarantee
that occurred. Paragraph 4.1.2 did no more than to state that laboratories
"should be" registered with an accreditation authority.
This is different from stipulating that laboratories must be accredited.
There is nothing in the language of paragraph 4.1.2 that compelled the
Department to ensure a laboratory became accredited. The paragraph does
no more than exhort laboratories to gain accreditation. In the Committee’s
view, once the importance of accreditation was accepted, and provision
made for it in the Policy, the design of the Policy should
have ensured that accreditation would happen.
5.60 In the 1991 Policy paragraph 4.1.2 contained
an expectation that laboratories that were not accredited would be given
a reasonable period of time to do so, (up to two years). This expectation
was ineffective. If laboratories resisted or were dilatory in taking steps
to gain accreditation there was nothing that the Department could do under
the Policy, or otherwise, to compel them to become accredited.
This was so, even though diagnostic laboratories reading cervical cytology
were fully paid for this service from government funds. The Committee
comments in its report on Term of Reference Three on the Ministry of Health’s
explanation for how this came about. What the Committee is concerned to
report on here is its view that a well designed cervical screening policy
is one which recognises the need for quality control and accreditation
of laboratories and is designed to ensure these features are in place.
The 1991 Policy could not do this. This is one of the reasons why
the Committee considers the 1991 Policy to be poorly designed.
Compulsory accreditation, based on the criteria in paragraph 4.1.4, would
have brought the practices followed at Gisborne Laboratories to an end.
In so far as the Policy permitted Gisborne Laboratories to continue
to practice its poor design is a factor that is likely to have led to
the under-reporting at Gisborne.
5.61 The criteria in 4.1.4 are important. For example:
the criterion regarding a minimum number of smears per annum. In 1991
and up to the time of Dr Bottrill’s retirement Gisborne Laboratories was
reading no more than 5000 smears per year. At the time the internationally
recommended minimum number was well in excess of this number. The World
Health Bulletin on Control of Cancer of the Cervix Uteri had stated
in 1986 that:
"Cytology services should be
centralised. A large volume of work contributes to the successful
operation of a cytology laboratory because a specialised division
of labour is possible and a large number of abnormal smears representing
various pathologies will help to maintain the cytotechnologists skills.
In general laboratories that screen fewer than 20,000 specimens annually
are not cost-efficient and cannot support either a training programme
or a full-time cytotechnologist Preferably the annual number of specimens
should be 50,000 or more.
A publication from the Council On Scientific Affairs,
American Medical Association JAMA 1989 Quality Assurance In Cervical
Cytology( exhibit RGB/MOH/3) reported that the American Society
of Cytology would only accredit laboratories that received a minimum of
10,000 gynaecologic smears per annum or maintained staff of at least one
cytopathologist and one full time cytotechnologist.
5.62 In the Review of the National Cervical Screening
Programme, which was written in 1990, Judith Straton reported on
the need for setting a minimum number of smear tests. She saw no practical
difficulty in implementing this requirement as she considered that smear
tests could be easily transported to those laboratories which were reading
a large number of smears and which could meet a compulsory minimum requirement.
She realised that a compulsory minimum number would exclude some laboratories
from reading cervical cytology but it appears to the Committee that in
her view this would only benefit the Programme. She said:
" The issue of the minimum number
of screening smears which are essential to maintain a competent screening
service is one which needs to be addressed. Apparently there are laboratories
in New Zealand which are reading fewer than 50 smears per year, compared
with the minimum in the Untied Kingdom of 15-20,000 smears
per year. Obviously with a smaller and more scattered population one
may not be able to use quite such stringent criteria, but communications
in New Zealand are good and smears can easily be sent from place to
place. This problem needs to be addressed urgently. It would
be very difficult for laboratories reading as few as 50 smears per
year to maintain a suitable level of competence or have any systematic
quality control, and this issue must be faced. Women have the
right to expect a minimum level of competence in the reading of their
smears."(emphasis added)
5.63 From the material the Committee has seen it is clear
that everyone working with the Programme thought, in principle, that a
compulsory minimum number of smears was needed to maintain screeners’
competence. And, that 5000 smears per annum was a low number of smears
to read in order to maintain competence. However, by setting a minimum
number the Programme would have excluded some laboratories, including
hospital laboratories, from reading cervical cytology. In New Zealand
cervical cytology had always been read by any laboratory that wanted to
do so. Furthermore, there was no history of the Department or the Ministry
of Health preferring certain laboratories to others when it came to funding
for diagnostic services. Therefor, the setting of a minimum number required
a major change in approach. It seems to the Committee that ultimately
the issue was too difficult to face and nothing was done, even though
the Policy intended a minimum number of smears to be set and everyone
recognised the benefits of laboratories which read a large number of smear
tests. Once again the Policy had no means of ensuring that its
intent was achieved.
5.64 The issue of setting a compulsory minimum number
of smears for reading per year was finally faced in 2000 by the Health
Funding Authority when, in its proposed standards for laboratories reading
cervical cytology, it proposed a minimum of 12,000 smears per year. The
rationale behind setting a minimum number of smears per annum is that
unless a laboratory processes a sufficient number of smears the screeners
cannot maintain their competence. Simply by ensuring that a set minimum
number of smears for reading each year (which reflected international
minimum numbers) was actually in force the Policy would have excluded
Gisborne Laboratories from reading cervical cytology.
5.65 Clause 4.1.3 placed the responsibility on the Department
of Health to confirm that laboratories carrying out cytology reading for
the policy met the requirements of 4.1.4. However, as accreditation was
not compulsory clause 4.1.3 had little effect, and the evidence is that
the Department of Health did little to ensure that laboratories met the
requirements set out in 4.1.4.
5.66 The Committee heard evidence from Mr Mules,
the former Chief Executive of the Midland Regional Health Authority. He
had previously been employed as the General Manager of the Bay of Plenty
Area Health Board. In this capacity he would have had experience of how
the Policy of 1991 worked in relation to area health boards. He
had also undertaken work for the Health Reforms Directorate of the Department
of Health. He appeared to the Committee to be a witness who was informed
about the Programme and how it functioned prior to the health restructuring
in 1993. He told the Committee that one of the aims of the Programme prior
to 1993 had been to introduce quality standards for laboratories reading
cervical cytology but that the method by which such standards would be
enforced was unclear to him as in his view there was no appropriate accountability
structure in place:
"One of the aims of the National
Cervical Screening Programme was to introduce quality standards around
the reading of slides by pathologists, a process that requires the
pathologist to exercise their professional judgement after actually
viewing the slide and cannot be automated. Those aims were explained
under the heading "Laboratories" at page 5 of the
1991 Policy". …
Mr Mules then referred to the 1991 Policy, which stated
that the Department of Health would be responsible for confirming that
laboratories carrying out cytology screening met TELARC requirements and
said:
"To my knowledge this was the
first time that an attempt was made to have private laboratories agree
with an external agency (in this case Department of Health) to develop
and implement quality standards. How this is to be enforced in
the absence of an appropriate accountability structure is unclear."
(emphasis added)
5.67 Mr Mules evidence on the 1991 Policy confirms
for the Committee the impression it gained from other evidence that the
1991 Policy was designed without any provision put in place to
enforce the Policy, should the need arise. The overall tenor
of the Policy as regards laboratories is to set out statements
that essentially describe good practice and then to leave it to the good
will of the laboratories to respond to these exhortations. In the Committee’s
view this is insufficient. A well designed Policy should require
laboratories to practise quality control and to be accredited with an
appropriate authority, and it should ensure that there is a means of compelling
laboratories to comply with the Policy’s intent if they fail to
respond.
5.68 When the Policy was updated in 1993, to take
into account the structural changes in the delivery of health services,
the amendments to clause 4 only exacerbated its poor design. It has already
been noted in the report that the two year time frame within which accreditation
was expected to be achieved was removed. More importantly, the
division of responsibility in the updated Policy between the new
Ministry of Health, (which had replaced the Department of Health), and
the four new Regional Health Authorities, (which had assumed much of the
Department of Health’s operational responsibilities), was poorly designed.
This was so even though the updated Policy described itself as
being:
" revised and updated to accurately
reflect the structural changes to the health sector, the changes to
the National Cervical Screening Programme and Register… The purpose
of this revision is to update the policy for regional health authorities,
the Public Health Commission and for cervical screening programme
managers and service providers. The update makes no changes to the
goals, objectives, or targeting sections of the 1991 policy document."
The wording of clause 4 remained the same except that
the Ministry of Health was substituted for the Department of Health and
the statement in clause 4.1.2 that TELARC accreditation may take up to
two years was removed. No account appears to have been taken of the new
policy-making and advisory role of the Ministry and its reduced ability
to carry out operational activities. This change from a government department
to a ministry with a policy-making role meant that the new Ministry of
Health was less well placed than the Department of Health to carry out
the role clause 4.1.3 gave to it.
5.69 The Ministry did consider whether it was appropriate
for the Programme to remain with the Ministry, given its role in the new
health structure. An internal memo of 18 March 1993 from Sonja Easterbrook-Smith
to the Director-General acknowledges that the role of nationally co-ordinating
the Programme was anomalous in a policy advice Ministry. Nevertheless,
a decision was made to retain that role, and the responsibilities the
Policy of 1991 had imposed on the Department of Health, within
the Ministry. Once a decision was made to retain those features of the
Programme within the Ministry, the 1993 updated Policy should have
been designed to ensure that the effective delivery of the Programme was
not compromised by any resulting anomaly.
5.70 Ms Judith Glackin, who gave evidence for the Ministry
of Health, told the Committee that the Ministry could not carry out the
role of confirming that laboratories met the criteria in 4.1.4 as the
Ministry had no means of discharging this task. She said that the Ministry
sought, instead, to discharge this task by ensuring that laboratories
were TELARC accredited:
"Paragraph 4.1.3 could be read
as intending that the Ministry would in some way be responsible for
confirming that laboratories were meeting all the criteria required
for TELARC registration. This was clearly not possible, as the Ministry
had no direct relationship or influence over laboratories after RHA
[ Regional Health Authority] contracts replaced the previous payment
arrangements under Part II of the Social Security Act 1964. Ensuring
that laboratories were accredited by TELARC or another suitable quality
assurance programme was seen as the way of ensuring that laboratories
met quality standards.
However, the evidence shows that the Ministry did nothing
to ensure that laboratories were TELARC accredited. All that it
did was to include in its funding agreements with the regional health
authorities a provision that they use " reasonable endeavours to
ensure" laboratory accreditation. To ensure something is done is
to make certain, to secure or to guarantee that it is done. Requiring
regional health authorities to use their "reasonable endeavours to
ensure accreditation" does not amount to making certain, guaranteeing
or securing accreditation. Thus the Ministry failed to discharge its responsibilities
in clause 4.1.3, however that clause may be interpreted.
5.71 The Ministry’s inability to perform the role clause
4.1.3 placed upon it was recognised by the Cytology Liaison Advisory Committee.
In June 1994, when the 1993 Policy was being reviewed, this committee
commented in a submission for the review that:
"The Ministry of Health does
not have the expertise and nor would it seem an appropriate function
of the Ministry of Health to confirm that laboratories were meeting
detailed requirements relating to TELARC accreditation."
However, because of delays in the completion of the policy
review the wording in the 1993 Policy remained unchanged until
a new Policy document was issued in June 1996. This was after Dr
Bottrill’s retirement.
5.72 Ms Glackin referred to the 1994/95 Funding Agreements
between the Ministry and the Regional Health Authorities which required
the authorities to use their "reasonable endeavours to ensure"
that all laboratories providing laboratory services for cervical cytology
and histology were registered with TELARC or an equivalent quality assurance
programme. She said that these funding agreements were between the Minister
and the Regional Health Authorities and that they were "the primary
accountability documents".
5.73 All the funding agreements from 1994 until 1997/98
refer to the 1991 Policy, even though that Policy was based
upon a health structure of a Department of Health and 14 area health boards.
The Committee received no explanation for why the funding agreements referred
to the 1991 Policy. Although the 1993 Policy had been updated
to make specific reference to the new health structure involving the Ministry
of Health and the regional health authorities the funding agreements failed
to record this. By the 1997/98 funding agreement a new policy had been
published in 1996 and the 1997/98 funding agreement referred to the new
Policy. The Committee was told that, the performance monitoring
branch of the Ministry of Health – which was the branch responsible for
issuing the funding agreements – was not advised about the updated version
and so until 1996 the funding agreements referred to the 1991 Policy.
Although the funding agreements may have referred to the 1991 Policy,
from the evidence it appears that everyone understood that it was the
1993 updated version that applied. It would have been difficult to apply
the 1991 Policy after the health restructuring as that Policy
allocated responsibilities to the Department of Health and the area
health boards.
5.74 Clause 10.4 of the 1994/95 funding agreement read
:
"10.4 The RHA agrees to use its
reasonable endeavours to ensure –
10.4.4 All laboratories providing
laboratory services for cervical cytology and histology -
(b) are registered with TELARC (the
Testing Laboratory Registration Council of New Zealand) or an equivalent
quality assurance programme;" (emphasis added)
Clause s4.11.5 of the 1995/96 funding agreement and clause
s5.3.20 of the 1996/97 funding agreement also repeated this requirement.
However, in addition to these clauses, clause 10.3 of the 94/95 funding
agreement, clause 4.11.4 of the 95/96 funding agreement and clause 5.3.19
of the 96/97 funding agreement, provided that the National Cervical Screening
Programme, and the cervical screening services, were to be consistent,
inter alia, with the Government Policy for National Cervical Screening
(1991).
5.75 Ms Glackin accepted that the impact of clauses 10.3,
4.11.4 and 5.3.19 was to incorporate the 1991 Policy document as
a term of the funding agreement :
"Q It seems that the 1991 Policy
was actually incorporated into the funding agreements for 94/95?
A Yes, that is how it reads.
Q And if you would turn next to the
funding agreements 95/96 and go to page 112, … once again the 1991 policy
document is made a term of the funding agreement is it not?
A It is
Q Anyone reading the funding agreements
seeing that the 91 Policy was part of the funding agreement and
going to the 91 Policy para 4.1.3 would conclude that the Ministry
of Health would be responsible for confirming that the laboratories
met the requirements set out in 4.1.4?
A Yes.
Q And I understand your evidence is
that practically speaking, because the Ministry had no direct relationship
or influence over laboratories, it couldn’t discharge its responsibility
which it had under 4.1.3 of the Policy?
A The mechanism available to the Ministry
was through the Regional Health Authority funding agreement and as you
have pointed out that referred to the 91 Policy so yes it would
appear that was the case.
Q So it seems then that the Ministry
… knowingly allowed itself to be placed in a situation where it could
no longer responsibly carry out its responsibilities under 4.1.3.
A I believe that’s the case and I think
the problem associated with this is the one I refer to later in my brief,
which is a delay in the review of the Policy. At the time the
Policy was reviewed in 1993 it was envisaged that the review
would be completed in 1994, in fact it was not completed until 1996
which meant that the Policy stood as it had been originally worded.
5.76 This means that, although the updated 1993 Policy
intended the Ministry to be responsible for confirming that laboratories
carrying out cytology screening for the Programme met the accreditation
criteria in clause 4.1.4, this could not be done and, therefore, it was
not done. Ms Glackin accepted that there was nothing about clause 4.1.3
which was ambiguous about the responsibility it conferred on the Ministry.
She accepted that on reading the Policy document it appeared the
Ministry was responsible for carrying out clause 4.1.3.
"Q The Policy document says
the Ministry of Health will be responsible and is it fair to say on
reading 4.1.3 there is nothing ambiguous about that responsibility?
A There is nothing ambiguous about the
wording, the problem there was no apparent way in which that responsibility
could have been carried out."
Thus the 1993 updated Policy, produced
by the Ministry of Health, gave to the Ministry a role which it could
not fulfil. Hence, between 1993 and 1996 the intent of the Programme's
policy document did not reflect the reality of the Programme’s delivery.
5.77 Mr Mules gave evidence on the 1993 Policy
which suggested to the Committee that the Midland Regional Health
Authority’s understanding of its responsibilities to the Programme was
confused by the difference in the allocation of responsibility in the
Policy and the Funding Agreements. He said that the Midland Regional
Health Authority had not treated the laboratory component of the Programme
as a priority because it considered that it was the Ministry’s responsibility.
He described the 1993 Policy in this way:
"The responsibilities of the Ministry
of Health, the Regional Health Authorities, Public Health Commission,
Cervical Screening Advisory Committee and the Cytology Advisory Liaison
Committee are explained at page 8 of the 1993 Policy. The responsibility
of the Ministry of Health for introducing quality standards around the
reading of slides by pathologists was continued from the role of the
Department of Health in the 1991 Policy."
For the Regional Health Authorities
the specific laboratory component of the National Cervical Screening
Programme was a relatively low priority because we believed that the
Ministry was responsible for it. Our National Cervical Screening Programme
priorities were enrolment of women, improving access to screening and
treatment services, and ensuring collection and communication of data
from the local programme directly to the Ministry."
5.78 Later in his evidence Mr Mules confirmed his
views on the relationship between the funding agreements under which the
regional health authorities were operating and the Government Policy
for National Cervical Screening. He said :
"Between 1991 and 1996 the Department/Ministry
of Health was responsible for laboratory quality in respect of the National
Cervical Screening Programme, covering both definition of the criteria
for TELARC registration, and confirmation of which laboratories were
eligible to carry out National Cervical Screening Programme screening
work. The Department/Ministry also controlled the data from the National
Cervical Screening Programme Register that allowed comparative monitoring
and analysis of laboratory activity. Midland did not have such access."
5.79 When Mr Mules was asked whether or not, to
his knowledge, the Ministry was aware that the Midland Regional Health
Authority did not consider itself responsible for confirming whether or
not laboratories were TELARC accredited, his response was that it was
commonly understood amongst all parties that the Regional Health Authority
focus was on enrolment and colposcopy in respect of the Programme.
"Q I want to be clear then, you
can only give evidence of your experience of dealings with the Ministry
during this time, but from your dealings with the Ministry did you gain
the impression that the Ministry was aware Midland Regional Health Authority
believed because of the cervical screening policy in 4.1.2 and 4.1.4
that the laboratory component of the Programme was the responsibility
of the Ministry.
A If you are referring to those aspects
of the laboratory components as described in 4.1.2 to 4.1.5, yes. I
was never party to any discussions that would have made people think
otherwise. We were responsible in the context of moving from section
51 to laboratory contracts that would have introduced TELARC registration,
but that was in a generic sense.
Q As I read your evidence you are saying
the Regional Health Authority believed the Ministry was responsible
for the laboratory component of the screening Programme.
A Yes, as laid out in Policy
guidelines.
Q The point is if that was the understanding
of the Regional Health Authority, then whether or not there was any
monitoring and evaluation of the laboratory component of the Programme
would depend very much on whether the Ministry recognised that it was
responsible for that part of the Programme, wouldn’t it?
A Yes, it would depend on their interpretation
of the Cervical Screening Policy and the funding agreement.
Q What I am trying to find out from
your knowledge is whether or not the Ministry was aware of the Regional
Health Authority view.
A I’ve got no reason to believe that
they weren’t, and Jane Hudson was in frequent communication with the
national co-ordinator and as you’ve seen from the service requirement
definition Jane has carried forward the Policy into those documents.
I would have thought she would not have done that if she had a contrary
view.
Q The outcome would be if the Regional
Health Authority relying on the documentation believed the Ministry
was responsible for the laboratory component of the Programme in terms
of monitoring and evaluation, but if the Ministry itself believed that
it couldn’t carry that out as heard from Ms Glackin, it would really
mean no-one was doing the job, wouldn’t it?
A One can assume that.
5.80 Mr Lambie was responsible for the unit that prepared
and negotiated the funding agreements. He was asked to comment on Mr Mule’s
evidence about the regional health authorities’ understanding of their
obligations under the funding agreements. Mr Lambie accepted that there
was some ambiguity between for example clause 10.3 and 10.4 of the 94/95
funding agreement, however, he said that no regional health authority
had taken this up with the Ministry at the time the agreements were being
negotiated:
"Q …if you go to 10.3… it says
the regional health authority is to purchase cervical screening services
…this Programme and the cervical screening services are to be consistent
with … the government’s 1991 policy for national cervical screening.
And then under 10.4 it says the regional health authority is to use
reasonable endeavours to ensure a number of things including TELARC
accreditation...I think the difficulty is that in 10.3 there is the
reference to the purchasing of service being consistent with the government's’1991
Policy. So I think what Mr Mules was saying, well under the 1991
Policy certain responsibilities remained with the Ministry …in
terms of paras 4.1.2 to 4.1.4 of the Policy therefore you you’ve
got a tension within the funding agreements between, by incorporating
the 1991 Policy, that puts a responsibility on the Ministry,
which also para 10.4 appears to be putting on the regional health authorities.
What do you do when you’ve reached the end of the year and you say "
well who should have done what?"
A I accept that there is some potential
ambiguity. However, if that ambiguity had been recognised at the time
I think it would have been cleared up. I think that the key part of
this funding agreement was under 10.4.
Q And to the best of your knowledge
did the regional health authorities ever say to the Ministry, "well
we actually think the incorporation of the government’s 1991 Policy
…means the Ministry has certain obligations about laboratory services
and cytology as set out in that Policy agreement which conflict
with our funding agreement responsibilities?
A To the best of my knowledge that never
occurred.
5.81 There was clearly confusion between the two health
agencies in relation to their respective roles under the 1993 Policy.
Each agency appears to have had its own interpretation of the responsibilities
that the Policy and the funding agreements placed upon them, and
they each appear to have been totally unaware of their different interpretations.
Because of this neither said anything to the other about the confusion.
5.82 The presence of this confusion is confirmed for
the Committee by the review that the Ministry of Health carried out for
the Associate Minister of Health in April 1996. At the time it was considered
that accountability arrangements between the Ministry and the Regional
Health Authorities were contributing to problems with the Programme. Ms
Glackin informed the Committee that the official’s report dated 11 April
1996 identified three key problems for the Programme. One of these was
confusion between the Ministry and the Regional Health Authorities over
"accountabilities for the Programme". The Ministry appears to
have recognised at the time of the review that the Regional Health Authorities
"saw themselves as purchasing a series of individual components which
contributed to a programme owned by the Ministry rather than purchasing
an integral service for women."
5.83 The practical effect of this confusion is that it
seems from 1993 until the new Policy in 1996 the Ministry of Health
considered that it could not carry out the responsibilities the Policy
placed upon it in clause 4 and, therefore, it did not specifically
attempt to do so. But the Regional Health Authorities were not stepping
into the breach created by the Ministry’s inability to carry out its responsibilities
because as they saw it the Policy placed the responsibility for
the laboratory component of the Programme on the Ministry. The end result
of this confusion was that little, if anything, was done in terms of clause
4 of the Policy.
5.84 Certainly, in response to their contractual requirements
under the funding agreements with the Ministry, the Regional Health Authorities
were working towards requiring all laboratories to gain accreditation
for all of their services. Even then, the funding agreements only required
Regional Health Authorities to exert "reasonable endeavours"
to achieve accreditation. But, as Mr Mules acknowledged, this was different
from the specialised accreditation that the Policy contemplated
in clause 4.1.4 for laboratories reading cytology for the Programme. The
funding agreements did not reflect the content of the Policy; they
made no attempt to distinguish cervical cytology laboratory services from
other laboratory services by requiring cervical cytology to be read only
by TELARC accredited laboratories. No one was doing anything meaningful
to ensure that the criteria envisaged in clause 4.1.4 were actually being
developed, and once in place adhered to. There were many discussions with
various advisory groups about what should be done, but ultimately nothing
meaningful was done by the Ministry in relation to its role in clause
4 of the Policy.
5.85 There is another aspect to this confusion. On 24 November
1994 the Women’s Health Action group wrote to the Minister of Health regarding
a woman’s false-negative smear result and asked, inter alia, what structures
were in place to monitor laboratory quality and what information did the
Programme have about false negative rates in laboratories used by the
Programme, how were false negative rates monitored and how were they reduced
in laboratories where the rate was high. The Associate Minister responded
to the Women’s Health Action group on 30 March 1995 by advising them that:
"A variety of measures are in
place or are being developed to ensure that the quality of smear reading
is as high as possible. The 1995/96 Policy guidelines for regional
health authorities state that regional health authorities must ensure
that all laboratories providing cervical cytology and histology services
are registered with … TELARC or an equivalent programme. The National
Cervical Screening Programme anticipates that all laboratories will
have TELARC (or equivalent accreditation) by the end of 1996. Several
years ago the cytology advisory liaison committee made a number of
recommendations to TELARC relating to performance of cytology in medical
laboratories. These recommendations which were accepted by TELARC
at that time, have been recently revised and upgraded and a provisional
list of recommendations is currently being considered by TELARC.
As part of the TELARC registration
process laboratories are required to demonstrate both internal and
external quality assu |