Contents
Opinion: Dr B — adverse comment
Appendix A: In-house clinical advice to Commissioner.
Appendix B: Alternative expert opinion report from [Dr G]
Introduction
- This report is the opinion of Dr Vanessa Caldwell, Deputy Health and Disability Commissioner, and is made in accordance with the power delegated to her by the Commissioner.
- The report discusses the care provided to Ms A (deceased) by Health New Zealand|Te Whatu Ora (Health NZ) Te Toka Tumai Auckland[1] and Dr B[2] between Month1 2019 and Month11 2020 (inclusive).[3] The complaint relates to the delayed diagnosis of ovarian cancer due to the inadequate processing of an electronic referral (e-referral) for an ultrasound scan.
- The following issues were identified for investigation:
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- Whether Health New Zealand provided [Ms A] with an appropriate standard of care between [Month1] 2019 and [Month11] 2020 (inclusive).
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- Whether [Dr B] provided [Ms A] with an appropriate standard of care between [Month1] 2019 and [Month11] 2020 (inclusive).
- Whether [Dr B] provided [Ms A] with an appropriate standard of care between [Month1] 2019 and [Month11] 2020 (inclusive).
- The parties directly involved in the investigation were:
Ms A (dec) Consumer
Dr B General practitioner (GP)
Ms C Complainant/daughter
Ms D Booking and reception administrator
Health NZ Provider
- Other parties mentioned in the report include:
Dr E Gastroenterologist
Dr F Gynaecologist
- Independent in-house clinical advice was obtained from GP Dr David Maplesden (Appendix A).
- Dr B provided HDC with an alternative expert opinion report from GP Dr G (Appendix B).
- Health NZ provided HDC with a copy of its Adverse Event Review (AER) report, which has been included throughout this report where relevant.
Timeline of events
- Ms A, aged in her early sixties at the time of events, had been experiencing gastrointestinal symptoms, which included a change in bowel habits (constipation) and weight loss.
- On 22 Month1, Ms A visited her GP, Dr B. It is documented that on the same day, Dr B referred Ms A to the Gastroenterology Service for a colonoscopy,[4] noting that the reason for the referral was suspected colorectal cancer. Following review of Dr B’s referral, Ms A was scheduled to undergo a CT colonography.[5] The indication for this was recorded as most likely an ‘outlet type’ bleeding disorder.[6]
CT colonography and findings
- Ms A underwent a CT colonography on 10 Month3, which reported an extracolonic finding of a pelvic mass[7] near her uterus. It is documented that a copy of the scan report was sent to Dr B on the same day.
- On 17 Month3 consultant gastroenterologist Dr E reviewed the scan report and advised Dr B of its results in a clinical letter. Dr E noted no areas of concern from a bowel perspective but indicated that there was a right-sided pelvic mass, which appeared solid, lobulated and was separate from the uterus. Dr E requested that Dr B take over clinical responsibility for further investigations, which involved making a referral for a pelvic ultrasound and a gynaecological referral.
- Dr B told HDC that both referrals had already been completed when he read Dr E’s letter, but he was ‘very assured’ by the letter and formed the impression that Ms A’s ‘gastrointestinal tract ha[d] been cleared and that ovarian cancer was most likely’.
Referrals made by Dr B
- Dr B stated that on the basis that ovarian cancer was the most likely diagnosis, on 17 Month3 he sent two e-referrals to Health NZ.
- At 5.42pm on 17 Month3 the Gynaecology Service received an e-referral for an urgent gynaecology review for a ‘pelvic mass’, which was noted to be ‘palpable’. The referral also noted: ‘[P]atient is post-menopausal.’[8]
- At 5.44pm, the Radiology Service received an e-referral for an urgent pelvic ultrasound. The referral noted the presence of a ‘pelvic mass on examination’.
- Both referral forms state ‘URGENT’ at the top of the form and note the incidental finding of a ‘60*65*50mm [right] adnexal[9] mass’.
- Health NZ told HDC that it does not send a specific notification to GPs that an e-referral has been submitted successfully; rather, the GP will see an acknowledgement (generated by the GP’s own software) that the referral has been sent. Clinical notes indicate that this acknowledgement occurred for both referral forms sent on 17 Month3.[10]
- Health NZ stated that at the time of events, an estimated 52 women were waiting for appointments at the Women’s Health Ultrasound unit, and the Radiology Service aimed to scan urgent outpatients within two weeks of referral. Health NZ told HDC that the two-week time frame was being met in Month3.
Ultrasound referral and blood test — CA 125
- Dr B told HDC that he received an email from the gynaecology clinic on 17 Month3, which requested that Ms A undergo tumour marker[11] blood tests for CA 125,[12] CEA,[13] and CA 19-9.[14] It is documented that Dr F declined the gynaecology referral due to ‘insufficient information’ and advised Dr B to arrange an urgent community-funded pelvic ultrasound scan (to obtain all tumour marker results) and then re-submit the referral (to enable the referral to be triaged to the appropriate service).[15]
- Dr B told HDC that he discussed the option of a community-funded ultrasound with Ms A, but this was not feasible ‘due to [a] lack of funding in the allocated practice budget’. Dr B stated that as a result, he discussed the option of a private ultrasound referral with Ms A, and it was determined that this was not affordable. Dr B said that given this, he discussed a likely timeframe (of several months) for the ultrasound scan and advised Ms A to seek medical attention if she experienced any gynaecological symptoms and inform him if she had not heard back from Health NZ within four to eight weeks. Health NZ received Ms A’s ultrasound referral on 17 Month3; however, it was not processed, and therefore no appointment was scheduled (discussed further below).
- On 18 Month3 Dr B requested a blood test to check for CA 125. In the request, Dr B noted the presence of a pelvic mass and stated that a copy of the results was to be sent to the gynaecological outpatient triage consultant.
- A blood test for CA 125 on 18 Month3 returned a result of 39 U/mL (with the normal range being between 0–5 U/mL). On the same day, it was documented in Dr B’s inbox report:
‘Elevated levels are not specific for ovarian cancer and may occur in other malignancies, pregnancies or in non-malignant disorders.
CA 125 is not suitable as a screening test.’
Gynaecological referral declined
- It is documented that Dr B received specific gynaecological advice on 23 Month3, which stated that there was ‘insufficient information to triage the referral’ and requested testing for additional tumour markers (CEA and CA 19-9). In his responses to HDC, Dr B said that he did not request the additional tumour markers at the time, for the following reasons:
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- Ms A had undergone a recent bowel investigation, and therefore requesting a CEA test was ‘redundant’ (as it is a tumour marker for bowel cancer).
- Ms A was being investigated for a pelvic mass, and therefore requesting a CA 19-9 test was ‘unnecessary’ (as it is a tumour marker for pancreatic cancer).
- The ‘[Health NZ] health pathway on ovarian cancer only discussed CA 125, not CEA (bowel cancer) or CA 19-9 (pancreatic cancer)’.
- He was under the ‘reasonable impression’ that a large right adnexal mass, a raised CA 125, and a recommendation from a senior gastroenterologist (Dr E) for a gynaecology referral would have qualified Ms A for an urgent gynaecological clinic appointment.
- Ms A had undergone a recent bowel investigation, and therefore requesting a CEA test was ‘redundant’ (as it is a tumour marker for bowel cancer).
- Dr B stated that in Month5 (when Ms A visited the clinic for another matter), he asked his receptionist to contact the Radiology Service to clarify the wait time for the ultrasound scan. Dr B said that they were not given any specific indication other than a ‘long wait’, and the radiology staff did not give any indication that the referral was not in their system.
Further visits to GP and admission to public hospital
- It is documented that Ms A visited Dr B several times over the following months — on 2 Month5 (illness), 13 Month6 (chest discomfort), 11 Month7 (injury), 3 Month8 (illness), 9 Month9 (constipation and bloating), 15 Month9 (epigastric bloating) and 20 Month9 (constipation and bloating). Dr B stated that despite needing attention for other health concerns, Ms A was ‘relatively asymptomatic with respect to her underlying malignancy until Month9’.
- On 6 Month10 Ms A visited Dr B after experiencing two weeks of abdominal bloating, epigastric pain and lower abdominal pain, four weeks of constipation, and a two-day history of vomiting. Dr B telephoned the on-call general surgical registrar about Ms A’s symptoms. The registrar considered that Ms A might have a bowel obstruction,[16] and she was referred to a public hospital.
- Ms A was admitted on 6 Month10 and underwent two CT scans (abdominal-pelvic and chest) on 7 Month10. The scans showed that the previously identified pelvic mass had progressed in size and appeared to be ‘carcinoma of mullerian origin[17]’. Ms A subsequently underwent two biopsies and was transferred to the Gynaecology Oncology Service, where a diagnosis of advanced ovarian cancer[18] was confirmed.
- On 27 Month10 a consultant medical oncologist discussed Ms A’s disease trajectory in an outpatient clinic appointment. It is documented that Ms A was ‘desperately keen’ to travel to China to see her parents and to seek medical treatment there; however, the oncologist was not prepared to provide Ms A with medical clearance to fly given the ‘risk of a sudden event leading to her death’ and a life expectancy that was ‘limited to weeks to months’. On 28 Month10 Ms A visited Dr B to discuss her treatment options and symptoms. It is documented that Ms A was ‘very scared’ about undergoing chemotherapy and wanted a surgical option.
Subsequent events
- Over the following months, Ms A received ongoing care and treatment. Unfortunately, her tumour proved resistant to chemotherapy, and, due to the progression of Ms A’s cancer and clinical deterioration, surgery was not an option. In 2021 Ms A was admitted to Mercy Hospice for end-of-life care. Ms A continued to deteriorate, and she passed away a month later. I offer my sincere condolences to Ms A’s daughter, Ms C, and Ms A’s wider family, for their loss.
Complaint — Health NZ and HDC
- Prior to her passing, Ms A complained directly to Health NZ about the failure of the referral system, which resulted in her delayed diagnosis of advanced ovarian cancer. Health NZ undertook an AER, which focused on the ‘process for managing radiology referrals from primary care which are received via e-referrals’.
- On 21 June 2021 HDC received a complaint from Ms C, on behalf of her mother, which stated:
‘[W]e believe my mum’s terminal cancer could have been prevented since the mass was identified back in [Month3]. There appears to be a failure in the referral system, along with us not knowing better about the aggressive nature and severity of gynaecological cancers since no one receives education or awareness on this (unlike breast cancer), it has resulted in the current state. If the referral was actioned when it should have, I believe we could have saved my mum’s life. We’re providing this feedback in hopes that this does not happen to another family again.’
- Ms A told HDC that while she was waiting for her ultrasound scan (from Month3 to Month10), she did not receive any information from Health NZ (besides a letter that stated that it had received ‘a recommendation from the doctor’) and she was forced to go to the Emergency Department in Month10 when her health worsened. Ms A said that she experienced ‘great emotional and physical damage’ because of a ‘loophole’ in the health system and wanted to prevent anyone else going through this ‘tragedy’ by telling her story.
Further information — Health NZ
AER report
- On 8 December 2021 Health NZ sent HDC a copy of the AER report, which outlined the following findings:
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- Finding One: There was effective and timely communication between the Gastroenterology Service, the GP, and the patient.
- Finding Two: There is no electronic interface between the Referral Management System (RMS) and Radiology Information System (RIS),[19] and therefore a manual transfer of information was required.
- Finding Three: There was no safety-net in place to ensure that all referrals received in RMS had been entered in RIS.
- Finding Four: The current workflow/process was not reflected in the process documentation.
- Finding One: There was effective and timely communication between the Gastroenterology Service, the GP, and the patient.
- The AER included the following five recommendations:
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- Resource a project to develop robotic process automation (RPA) [20] capability to transfer information from the RMS to the RIS.
- Assess the lack of system integration and enter any identified risks on the Clinical Support Directorate risk register.
- The Radiology Service explore the option of providing primary care with visibility of booked radiology appointments in the hospital system using the RIS/ECLAIR interface.
- Develop and implement a robust process to identify and action any discrepancies between referrals received in the RMS and referrals loaded in RIS.
- The Radiology Administration Services review all their desk files/process documentation to ensure that they are current and reflect current practice.
- Resource a project to develop robotic process automation (RPA) [20] capability to transfer information from the RMS to the RIS.
Referral Management System and Radiology Information System
- As reflected in Findings Two, Three and Four, Health NZ acknowledged that there was a systems breakdown in the process for primary care radiology e-referral in Ms A’s case, as the referral was received but not processed appropriately by the booking/reception administrator, Ms D (discussed further below).
Need for manual transcription into RIS
- Health NZ told HDC that the manual transcription of referrals was required, as information received by the RMS could not be ‘picked up’ by many of Health NZ’s core systems, including the RIS.[21] Health NZ stated that at the time of events, the Radiology Service was aware that the e-referral system did not provide full integration, [22] and that ‘on occasion individual referrals did not result in scans occurring’, which led to individual investigations.[23]
Process for primary care radiology e-referrals
- Health NZ told HDC that at the time of events, the process for primary care radiology
e-referrals involved the following steps:
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- The GP submitted an e-referral.
- The referral was received via the Regional Clinical Portal (the RMS inbox) and was printed and ‘outcomed’.
- The referral information was manually transcribed and scanned into the RIS by the ultrasound scanning and mammography department reception staff (reception staff).
- The referral was prioritised by clinical staff in the RIS.
- An appointment was sent to the patient via the RIS, and subsequently the patient would undergo the scan.
- The GP submitted an e-referral.
- In addition, Health NZ’s standard operating procedure (SOP) for ‘Entering QP Orders’ stated:
‘PROCESS TO FOLLOW
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- Referrals are usually received through the eReferrals System in RCP/Concerto/ Fax/Internal and External Mail.
- The eReferrals received via Concerto are printed off by a delegated staff member and placed in the appropriate tray to be entered onto the system …’
- Health NZ stated that in Month3 it was accepted practice for a referral to be printed by one staff member and entered and scanned by another staff member. It acknowledged that simultaneously staff were required to carry out other reception duties and administrative tasks (alongside processing each referral),[24] and, at the time of events, ‘there was no reconciliation process in place to check that the referrals that had been received in RMS had been loaded into RIS’.
RMS system logs
- Health NZ stated that on 18 Month3 the RMS system log recorded the following:
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- The referral was printed at 7.53am.
- At 7.54am the referral status was registered and noted as ‘Completed with outcome (Triage workflow disabled)’.
- However, there is no record that the ultrasound referral was entered into the RIS.
Statement from Ms D
- Health NZ provided HDC with a statement from Ms D[25] (dated 17 October 2022). Ms D said that the error occurred at the ‘exact time’ of her transition to the public hospital, in Month3. She stated:
‘While [I was] training for CT bookings, our new scheduler in Ultrasound resigned after a few weeks. I was asked to help cover Ultrasound bookings while our cover person at the time was away on annual leave.’
- Ms D said that she was required to cover ultrasound bookings between 9 Month3 and 23 Month3, alongside completing many additional tasks.[26] She stated that ‘there was an overwhelmingly excessive amount of work required of [her] during [this period]’, and it was not always possible to load the e-referral immediately, due to the ‘extremely busy reception area’ and resource limitation (only one PC monitor was available at the time). Ms D recalled having to work on the weekends to get through the workload, namely the loading of e-referrals.
- Ms D noted that the job description has ‘drastically changed since 2019’, and there is now a more streamlined process, which has ‘removed a lot of pressure off the current scheduler’.
Further information — Dr B
Practice policy — task manager
- Dr B provided HDC with a copy of the medical centre’s ‘Patient test results and reports management policy’, which stated:
‘If a Doctor suspects significant pathology, the Task Manager within MedTech is used to set a reminder to check if the results have been received back. A reminder is placed on Task Manager for those tests classified for tracking.
This applies to bloods, radiology and referrals.
Doctor checks Task Manager daily and these results will show up in the list of tasks if they have not been completed by the time set up.
Use the Task Manager to follow up hospital/specialist referrals where significant pathology is suspected e.g. breast lumps, gastroscopy/colonoscopy referrals by adding a task to the list with a future date. This will show up on the task list when it becomes overdue.
Patients are also to be verbally reminded to let their Doctor know if they have not heard from the hospital/specialist within a certain time frame (4–8 weeks) if there is concern about the condition. Patients who have been referred to secondary care can be given the phone number to ring the hospital reception to check themselves on the progress of their referral.’
- Dr B told HDC that he did not set a formal task reminder as he believed that the confirmed ultrasound scan was in Health NZ’s system and that Health NZ would contact Ms A directly. Dr B said that once he received the ultrasound report, he planned to write another letter to ensure that the gynaecologist had also received the report and would see Ms A. However, as the ultrasound request was not entered into Health NZ’s electronic system, this did not occur.
Alternative opinion report — Gynaecology Service
- Dr B provided HDC with an opinion by Dr G. Dr G noted that the Gynaecology Service’s response to the ultrasound referral was ‘quite concerning’ and unusual, given that:
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- ‘It is well established that the only definitive diagnosis of an ovarian mass is through histology’; and
- Regardless of the impact of the ultrasound scan on a diagnosis, it would ‘in no way alter the fact that [Ms A] required an urgent laparotomy’.
- ‘It is well established that the only definitive diagnosis of an ovarian mass is through histology’; and
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- Dr G stated that it was a ‘serious system failure’ that Ms A was consigned to wait for several months, instead of being booked for a priority one appointment.
- In response, Health NZ said that it does not accept these criticisms about the gynaecology triaging, as it was ‘completely within guidelines’. Health NZ stated:
‘[A]n urgent pelvic ultrasound was recommended as well as completion of tumour marker workup to allow a Risk of Malignancy Index (RMI) to be calculated, which is standard practice.’
- Health NZ said that clinical responsibility remained with the GP, as the e-referral system could not assign clinical priority ‘without the full clinical information’.
- In response to Dr G’s opinion, Dr F told HDC that Dr B did not indicate that Ms A was ineligible for a pelvic ultrasound scan, and had he done so, she would have annotated the advice with the following comment in accordance with her routine practice: ‘[P]lease use my name for specialist endorsement.’
Responses to provisional opinion
Ms C
- Ms C was given an opportunity to respond to the information gathered during the investigation and had no further comments to make.
Health NZ
- Health NZ was given an opportunity to respond to the provisional opinion and stated that it agreed with the recommendations below. Further comments made by Health NZ have been incorporated into this report where relevant.
Dr B
- Dr B was given an opportunity to respond to the provisional opinion. Dr B stated that it is not uncommon for a referral (such as an ultrasound scan) to take more than a year to occur in some areas. He stated that GPs are given ‘vague suggestions’ as to when these investigations will be booked, which results in GPs having to chase up a single referral multiple times before it is done. Dr B reiterated that he did chase up Ms A’s referral, but she did not have increasing symptoms (which would have triggered a further referral).
- Further comments made by Dr B have been incorporated into this report where relevant.
Opinion: Health NZ — breach
- Under Right 4(1) of the Code of Health and Disability Services Consumers’ Rights (the Code), health providers owe a duty of care to consumers to provide health services with reasonable care and skill.[27]
- This case involves two services within Health NZ — the Radiology Service and the Gynaecology Service. I will address each service separately, but I note that ultimately Health NZ is responsible for both services.
Radiology Service — breach
- On 17 Month3 Dr B sent and received acknowledgement of his e-referral request to the Radiology Service for an urgent pelvic ultrasound. However, Ms A did not hear from the Ultrasound Department. Approximately six months after the referral was sent, Ms A presented to [the public hospital] when her health worsened in Month10.
Systems limitation and process documentation
- Health NZ acknowledged in finding two of the AER report that there was a ‘systems limitation’ between the RMS and RIS. This meant that referrals received through the RMS could not be electronically transferred into the RIS and required a manual transfer of information. However, as discussed at paragraph 37, at the time of events, Health NZ was aware of this systems limitation and of further incidents of referrals having been received and the outcome noted as having been completed but not entered into the RIS (which resulted in individual referrals not occurring).
- In finding three of the AER report, Health NZ acknowledged that there was no safety-net in place to ensure that all referrals received in the RMS were entered into the RIS. It stated that it had attempted to facilitate the cross-matching of referrals received versus those loaded but had been advised that it was ‘not in an easy to use format and required a lot of rework’. Therefore, no reliable process was in place to carry out a reconciliation task.
- Further, in finding four of the AER report, Health NZ acknowledged that the ultrasound booking and task list document did not reflect the process for managing ultrasound referrals.
- I accept Health NZ’s findings in respect of the systems limitations that exist between the RMS and RIS. I also note its submission that in 2013/2014 the Radiology Service was advised against full integration (due to several factors, including cost and time[28]), and on that basis, no further work on the integration occurred.
- However, I am critical that Health NZ has not conducted an assessment of its e-referral system since 2013/2014. This is particularly concerning given the further incidents of error in the e-referral system (which resulted in Health NZ conducting its own individual investigations). It is regrettable that in the absence of adequate checks and balances on the e-referral system, a data entry error made by a booking and reception administrator resulted in a significant delay in the provision of care to Ms A.
- In my view, Health NZ was aware of the clinical risk present (due to the lack of systems integration) but failed to implement adequate measures to prevent patient harm. I consider that this case illustrates wider systemic issues within Health NZ, including a lack of ongoing monitoring and evaluation of the e-referral system.
- I remind Health NZ that keeping process documentation up to date ensures that strategies are in place for risk management and harm minimisation.
Ultrasound referral not processed
- Health NZ’s policy stated that the process for primary care radiology e-referrals involved the e-referral being ‘printed and outcomed’. However, the booking and reception administrator, Ms D, did not enter the referral into the RIS. As outlined previously, the failure to process Ms A’s e-referral appropriately was due to human error. I acknowledge Ms D’s comments about the lack of staff, workload pressures, and ongoing training requirements at the time of events.
- As shown by this case, the processes in place relied on manual completion by staff (despite the transition from paper-based referrals to e-referrals over the past decade). In my view, Health NZ failed to recognise the clinical risk created by the lack of support provided to new staff. Accordingly, I remind Health NZ that it must ensure that its staff receive suitable and adequate training, instruction or supervision, with supporting policies and guidelines.[29]
Communication
- The Code provides consumers with the right to effective communication[30] and the right to be fully informed.[31] I consider that Ms A should have received further communications from Health NZ about the status of her referral, [32] including ‘advice of the estimated time within which the services will be provided’.
- I highlight that given the current pressures on the health system, transparent communication is essential in managing consumer expectations and shared decision-making. A well-informed consumer can act as an additional layer of vigilance and protection against errors (such as an unreasonably long wait for a secondary-care appointment).
Co-operation among providers
- The Code also provides consumers with the right to co-operation among provides to ensure quality and continuity of services.[33] I consider that Health NZ should have made further internal enquiries about the status of Ms A’s referral when contacted by Dr B’s receptionist on 2 [Month5], and subsequently it should have provided an update to Dr B directly.
- My independent clinical advisor, Dr Maplesden, told HDC that there appears to be a ‘complete lack of understanding by [Health NZ] of the burden placed on primary care when resubmitting of already completed referrals is required, and in the requirement to track referrals to secondary care, essentially because of the unreliability of secondary care processes’. In my view, Health NZ has a responsibility to proactively communicate with primary-care providers, particularly where a risk of patient harm exists due to inefficiencies in its referral system.
Conclusion
- As discussed in this report, I consider that the primary reason for the delayed diagnosis of Ms A’s cancer was systemic issues within Health NZ (as opposed to the error made by Ms D or an oversight on the part of Dr B). In my view, this case demonstrates a critical systems issue within Health NZ, as it failed to implement adequate measures to prevent patient harm caused by the lack of systems integration, it did not keep process documentation up to date or communicate effectively in relation to the ultrasound referral, and it did not recognise the clinical risk created by the lack of support provided to new staff. Accordingly, I find Health NZ in breach of Right 4(1) of the Code.
- I note that currently in New Zealand, there is no effective screening test for ovarian cancer,[34] and therefore, the timeliness of referrals plays a critical role in the prompt recognition and investigation of suspicious symptoms.
Gynaecology Service — other comment
- In Month3, Dr F declined Dr B’s request for an urgent ultrasound scan, on the basis of insufficient information to triage the referral.Upon review of relevant documents[35] provided by Health NZ in response to the provisional opinion, it appears that Dr F’s triaging of Dr B’s referral was consistent with the triage guidelines. I note that Health NZ stated that in Month3 it was meeting the two-week time frame to scan urgent outpatients; therefore, it is likely that the Gynaecology Service reasonably expected this to occur in Ms A’s case. Therefore, I have no criticisms to make in respect of this issue.
- While the Gynaecology Service was not within the scope of Health NZ’s AER report, I note that Health NZ has outlined an intention to follow up on the Gynaecology Service’s management of Ms A’s e-referral. [36] I look forward to Health NZ outlining its progress on this matter and have made relevant recommendations below.
Opinion: Dr B — adverse comment
Additional tumour markers
- As outlined above (paragraph 24), Dr B did not request the additional tumour markers (CEA and CA 19-9) as he believed it would be ‘redundant’ and ‘unnecessary’, and the HealthPathways advice discussed only CA 125. Dr B was under a ‘reasonable impression’ that Ms A would qualify for an urgent gynaecology clinic appointment.
- Dr Maplesden advised that Dr B’s failure to complete the additional requested tumour markers constituted a mild departure from the accepted standard of practice, as CEA and CA 19-9 have a limited role in the diagnosis of ovarian malignancy. Dr Maplesden considered that Dr B should have sought clarification from the Gynaecology Service about the reason for its request.
- Although Dr B explained his clinical reasoning for his decision, I am critical that he did not seek clarification when he was unwilling to order the additional tests.
Management of referral
- Ms A waited for her ultrasound scan from Month3 to Month10 (a six-month delay in receiving appropriate care).
- Dr Maplesden advised that Dr B’s failure to confirm Ms A’s ultrasound appointment when there was a four- to five-month delay from when the appointment was expected (Month7 to mid-Month8) constituted a mild departure from the accepted standard of practice at the time of events. Dr Maplesden stated that in the interests of patient safety and wellbeing, it is important for primary-care providers to track referrals to secondary care and provide updated referral information when relevant, to ensure that management is undertaken in a timely manner.
- Dr Maplesden also advised that Dr B’s failure to track the referrals formally as per the practice policy constituted a mild departure from the accepted standard of practice at the time of events. However, Dr Maplesden noted that it is unclear whether such tracking would have altered Ms A’s outcome, given that the scheduling of the first gynaecology specialist appointment was dependent on receipt of the ultrasound referral, it was Dr B’s understanding that Ms A was on the ultrasound waiting list for an unspecified ‘long’ period, and in Month9, the COVID-19 pandemic ‘undoubtably influenced’ the management of care.
- Dr Maplesden advised that Ms A’s delayed diagnosis was due to process failures and inefficiencies in secondary care, as opposed to an oversight by Dr B. Dr Maplesden noted that it is difficult to see what Dr B could have done to expedite Ms A’s ultrasound referral, given that there was no major change in her overall clinical picture until late Month9 or Month10, and Dr B attempted to clarify the wait time in Month5 (via his receptionist).
- I accept this advice, but I consider that Dr B should have set a formal task reminder for Ms A’s ultrasound scan referral, as this critical patient-safety mechanism would have alerted Dr B to the excessive delay. I remind Dr B that adherence to SOPs is a requirement under the Code[37] and is part of good medical practice.
- In addition, I highlight Dr Maplesden’s recommendation that given an emerging trend of deficiencies in the processing, triaging, and management of e-referrals by Health NZ, it would be preferrable for referrers to ‘maintain the referral as incomplete until the service being requested has been undertaken’. While noting that this may be burdensome on primary care, Dr Maplesden considers that this would provide an additional safety back-up (which ultimately is in the best interests of consumers).
- In response to the provisional opinion, Dr B stated that this recommendation does not reflect the reality of current primary care, as GPs often rely on clerical staff to make enquires on behalf of them due to workload pressures. I acknowledge that this is reasonable and accepted practice, and in such cases, it is important that the referrer is made aware of the result of the enquiry and takes appropriate action in light of the response. However, when there is a clinical practice enquiry (such the request for additional tumour markers), there is an expectation that the enquiry is made by a clinician (referrer or practice nurse).
- Dr B also submitted in response to the provisional decision that tracking referrals come at a significant cost to practices (in terms of financial cost and time away from direct patient care). In my view, the need to track a referral and the intensity of tracking is dependent on the clinical context. In this case, there was an urgent referral with a high suspicion of cancer, which necessitated a greater need for tracking (such as through the use of formal task reminders).
Conclusion
- I acknowledge the ongoing pressures in primary care, particularly around workload, resourcing, and the enduring impact of the COVID-19 pandemic, and I commend Dr B for his willingness to review his practice and make appropriate changes.
- Nevertheless, I consider that deficiencies in the care provided by Dr B affected the overall standard of Ms A’s care. I remind Dr B that as the access point to secondary care, GPs should use the processes in place to follow up referrals and ensure that appropriate action has been taken.
- I encourage Dr B to act proactively and with a degree of urgency when managing patient referrals in his future practice, particularly when a life-threatening disease (such as a suspected malignancy) is involved and there is a significant time delay. As demonstrated in this case, reasonable steps may include:
-
- Seeking clarification from the specialist about the reasons for the referral, particularly when there is uncertainty, and it is outside the GP’s ‘scope of practice’;
- Ensuring that there is adequate tracking of referrals to secondary care, including adherence to formal referral tracking requirements contained in policies and procedures; and
- Providing updated referral information to patients, so that they are adequately informed about the need for the referral and are vigilant in following up.
- Seeking clarification from the specialist about the reasons for the referral, particularly when there is uncertainty, and it is outside the GP’s ‘scope of practice’;
Changes made since events
Health NZ
System integration
- Health NZ told HDC that ongoing work is occurring at a regional level to address integration between e-referrals and RIS (and other Health NZ systems), including the development of a ‘Health Provider Directory’. Health NZ stated that the development of a reliable and maintainable database for the details of practitioners, organisations, facilities and practices, and their relationships is the first step in fully integrating the two systems and improving this system limitation.
- Health NZ said that alongside the Health Provider Directory, it is investing in RPA, which will enable information to be transferred from the RMS and entered into the RIS accurately and quickly. Health NZ stated that largely this would remove the potential for human error.[38]
- However, Health NZ noted that attempts at integration are influenced by the planned replacement of the district’s core Patient Administration System. As a result, ‘[a]ny attempts at integration would therefore not be possible in the short to medium term’.
Processing ultrasound referrals — booking clerks
- Health NZ stated that a team of booking clerks[39] now processes primary-care ultrasound referrals. In contrast to the events of this complaint, booking clerks do not have the additional responsibility of working on the reception, and the task is now completed only once per day (at a time with minimal distractions), in a non-patient-contact area. In addition, one person is now required to print, outcome, and load the referral into the RIS.
Cross-referencing referrals — Radiology Service
- Health NZ stated that since 1 August 2021, the Radiology Service has received a weekly report to check that all referrals printed out of the RMS have been entered into the RIS. The Radiology Service is in the process of developing a way to cross-reference the data (referrals received versus referrals loaded) to identify any missed referrals.
Auditing procedure for GP e-referrals
- Health NZ stated that there is now a standard operating procedure for a weekly audit of GP e-referrals in the Radiology Service, to ensure that all referrals received in the RMS are manually transferred to the RIS. This involves the Clerical Team Leader reviewing an
e-referral audit spreadsheet weekly to highlight any referrals that have not been loaded into the RIS. If any missed e-referrals are identified, the relevant clerical staff are messaged to load these as soon as possible. Once loaded, the Clerical Team Leader is informed, and the e-referral is re-audited monthly to ensure that it has been attended to and uploaded.
Wider health system changes
- In June 2024, it was announced that Health NZ would be allocated funding to improve access to radiology services.[40] A key change will be the ability of GPs to refer consumers directly to the Radiology Service, without the need to wait for a specialist to review and approve the referral request.
Dr B
- Dr B told HDC that he has taken on board learning from this incident to ensure that he can ‘minimise any risk of a shortcoming like this from occurring again’. He said that he now undertakes the following:
-
- Sets a task reminder for ‘every significant result/referral, even where the hospital acknowledged the receipt of the referral, and the patient is on a waiting list’;
- Documents that he has verbally reminded the patient to contact the GP clinic if they have not heard from Health NZ within 4–8 weeks, and patients are given a phone number to check the progress of their referral;
- Keeps abnormal results unfiled in the inbox to ensure that they are in daily view until actioned; and
- He will re-refer a patient if there is a suspicion that a systems error has occurred.
- Sets a task reminder for ‘every significant result/referral, even where the hospital acknowledged the receipt of the referral, and the patient is on a waiting list’;
-
Recommendations
Health NZ
-
- Provide a written apology to Ms C for the deficiencies in care provided to her mother, Ms A, as outlined in this report. The apology is to be sent to HDC within three weeks of the date of this report, for forwarding to Ms C.
- Provide HDC with an update on the recommendations and follow-up actions made in the AER, within three months of the date of this report, including but not limited to:
- The actions taken on ‘Follow-up action 1’ in the AER;
- Any further incidents of e-referral errors (and internal investigations);
- The radiology reception document, noting the review date of 30 Month 11; and
- The radiology service’s SOP for auditing procedure for GP e-referrals (CL 1032 BK), noting the review date of 10 October 2023.
- Provide a written apology to Ms C for the deficiencies in care provided to her mother, Ms A, as outlined in this report. The apology is to be sent to HDC within three weeks of the date of this report, for forwarding to Ms C.
Dr B
- In accordance with the proposed recommendations in my provisional opinion, Dr B has provided HDC with a written apology to Ms C and two audits of compliance (regarding changes made since the events and the ‘Patient test results and reports management policy’). I consider that Dr B’s apology is reasonable, and the audit requirements have been met and show quality improvement between audit cycles. Given this, I have no further recommendations to make in respect of Dr B.
Follow-up actions
- A copy of this report with details identifying the parties removed, except Health NZ Te Toka Tumai Auckland and HDC’s advisor on this case, will be sent to the Medical Council of New Zealand, and it will be advised of Dr B’s name.
- A copy of this report with details identifying the parties removed, except Health NZ Te Toka Tumai Auckland and HDC’s advisor on this case, will be placed on the Health and Disability Commissioner website, www.hdc.org.nz, for educational purposes.
Appendix A: In-house clinical advice to Commissioner
The following clinical advice was obtained from GP Dr David Maplesden:
‘FINAL CLINICAL ADVICE — MEDICAL
…
DATE: 19 September 2022; Addendum 18 July 2023 (s 13, 14); Addendum 19 December 2023 (s15)
1. My name is David Maplesden. I am a graduate of Auckland University Medical School and I am a practising general practitioner. My qualifications are: MB ChB 1983, Dip Obs 1984, Certif Hyperbaric Med 1995, FRNZCGP 2003. Thank you for the request that I provide clinical advice in relation to the complaint from [Ms C] about the care provided to her late mother, [Ms A], by [Health NZ]. In preparing the advice on this case to the best of my knowledge I have no personal or professional conflict of interest. I agree to follow the Commissioner’s Guidelines for Independent Advisors.
2. I have reviewed the following information:
- Complaint from [Ms A] per her daughter [Ms C]
- Response from [Health New Zealand|Te Whatu Ora Te Toka Tumai Auckland]
- Clinical notes [from the public hospital]
- [Health NZ] Serious Event Report
- GP notes
- Response received from [Dr B] 1 October 2022
3. The complaint relates to delays in the diagnosis of ovarian cancer. [Ms A] had been undergoing investigations for abdominal pain and had a CT colonography performed on 10 [Month3] with an incidental finding of a right adnexal mass 60x65x50mm. On 17 [Month3] [Ms A’s] GP, [Dr B], referred her to [Health NZ] for urgent gynaecology review. [Ms A] states she got a letter back from the hospital saying that they had received a recommendation from the doctor, but there was no arrangement at all. [Ms A] received no further information from [Health NZ] and in [Month10] she attended [a public hospital] ED because of worsening abdominal pain. Here she underwent an abdominal CT which confirmed the adnexal mass had grown considerably and was now inoperable. Sadly, [Ms A’s] tumour proved resistant to chemotherapy and in 2021 she was referred for hospice care, succumbing to her disease two months later.
4. The [Health NZ] response notes a referral for urgent ultrasound examination was received from [Dr B] on 17 [Month3] and there was a reciprocal acknowledgement to [Dr B] that the referral had been received. There was no additional communication with the GP and no direct communication with [Ms A] (contrary to the complaint). It appears the ultrasound request was never entered into the [Health NZ] radiology information system (RIS) and there was no further action taken. A serious event review (SER) was undertaken by [Health NZ]. The SER report notes [Dr B] sent two electronic referrals to [Health NZ] on 17 [Month3] — the ultrasound request described above and a concurrent urgent gynaecology request noting an incidental finding of a pelvic mass during investigation of GI symptoms. The report notes cancer marker Ca-125 had been requested by the GP on 18 [Month3] and was mildly elevated (38 U/L — reference range 0–35 U/L). Additional tumour markers CEA and Ca 19-9 had not been performed and the referral was declined with request to the GP to arrange urgent community ultrasound, to arrange testing for the additional markers and then to resubmit the referral. The SER report notes there was no further contact from the GP in relation to the ultrasound or gynaecology referrals, and the additional tumour markers requested as part of the gynaecology referral decline were not completed until [Ms A] was admitted to hospital in [Month10]. The ultrasound referral was never scanned onto the RIS and the SER examines likely contributors to this error and remedial measures since undertaken. It is unclear if the contact from [Health NZ] [Ms A] refers to in her complaint was related to the gynaecology referral but this seems most likely.
5. GP notes were requested from 1 [Month3] to 20 [Month10]. [Ms A] had apparently been assessed by the gastroenterology service and as part of this she underwent CT colonography on 10 [Month3]. While GP notes do not cover the period prior to receipt of the colonography result, the [Health NZ] SER includes the following comments: On 22 [Month1] [Ms A], a 60 year old female patient, was referred by her GP to the … Gastroenterology Service for a colonoscopy, due to symptoms of change in bowel habit (constipation) and weight loss. There was a concern that her symptoms may represent a colorectal cancer. The GP referral also requested that [Ms A] be provided with [an] interpreter. The GP referral was reviewed the same day and the clinical suspicion of the Gastroenterologist was one of an outlet type bleeding disorder and as such it was felt that [Ms A] should undergo a CT colonography. A plan for the gastroenterologist to order the scan and then to review the scan once completed was communicated back to [Ms A] and her GP via a clinical letter dated 28 [Month1]. In this letter [Ms A] was advised that [an] interpreter had been requested to be present at the time of her scan. On 10 [Month3], [Ms A] underwent her CT colonography scan. A copy of the scan report (also reported on 10 [Month3]) was electronically sent to [Ms A’s] GP. The CT scan results were reviewed by the referring Gastroenterologist on 17 [Month3]. The Gastroenterologist wrote a clinical letter back to [Ms A’s] GP the same day advising of the results of the scan. Specifically the Gastroenterologist outlined that from a bowel perspective it was a good quality scan with no suspicious colonic lesions seen. It also outlined that the scan had shown:
“a right sided adnexal mass measuring 60 x 65 x 50 mm, which appears solid and lobulated. It is separate from the uterus.”
The Gastroenterologist requested that the GP follow up this finding with referrals for a pelvic ultrasound scan and a referral to the gynaecology service. The letter also documented that they would telephone the GP practice to alert the GP to the results.
6. A letter to [Dr B] from [Health NZ] gastroenterologist [Dr E] dated 17 [Month3] notes the CT colonography result and concludes: Hence, all very reassuring from the lower bowel point of view but clearly the right sided pelvic mass should be investigated further with pelvic USS and generate a gynaecological referral. Please could I leave this with you? I will ring your surgery now to alert you to the result if you have not already seen it. [Dr B] has recorded on 17 [Month3]: referred gynaecology … referred pelvic ultrasound. Patient informed 17 [Month3] 5.35pm, no reply on land line — told on her mobile, cut off. Told daughter [Ms C], left message to come and see GP ? do CA125 next visit. Both referrals were marked urgent and included a copy of the CT result. The gynaecology referral noted: incidental finding of 60x65x50m R adnexal mass on CT colonoscopy … The following are present: Abdominal or pelvic mass that is palpable; Patient is post-menopausal. On 17 [Month3] an electronic message was received from the gynaecology service noting [Dr B’s] gynaecology referral was declined because of insufficient information. [Dr B] was requested to arrange urgent community-funded pelvic ultrasound scan. The message included: I note that the Ca-125 is only mildly elevated. CEA and Ca 19-9 should also be performed. Please submit a referral with the ultrasound scan report and all tumour marker results so that we can triage your patient to the appropriate service in a timely fashion.
On 18 [Month3] [Dr B] has recorded reviewing [Ms A] noting she had mild right iliac fossa tenderness but no reference to a palpable mass. Blood test form was provided for CA-125 measurement with copy of the result to go to gynaecology outpatients department. As discussed above, the level was mildly elevated.
7. On 2 [Month5] [Dr B] reviewed [Ms A] for repeat of a WINZ sickness certificate. An elbow rash was reviewed concurrently. There is no reference to discussion regarding the ultrasound or gynaecology review. A normal mammogram screening report was received on 14 [Month5].
8. Prior to pandemic precautions coming into force [Ms A] attended [Dr B] in [Month6], [Month9] and [Month8]. On 13 [Month6] she presented a history of non-specific chest discomfort a few weeks previously, achy upper back and possible slow pulse intermittently. Past history of non-cardiac chest pain was noted (seen by the [Health NZ] cardiology service in 2016). Vital signs were normal with some musculoskeletal tenderness noted in the chest wall posteriorly and concurrent pharyngitis. Script provided for cefaclor and paracetamol and routine CV screen blood tests undertaken (results 15 [Month6] showed elevated HbA1c consistent with impaired glucose tolerance and mildly abnormal lipid profile but all other results within reference parameters). On 11 [Month7] she presented left shoulder symptoms after moving a heavy bed. Diagnosed as shoulder sprain and referral made for acupuncture with script for analgesia (paracetamol, celecoxib) and gastric protection (pantoprazole). On 3 [Month8] [Ms A] attended [Dr B] for renewal of WINZ benefit forms. New symptoms of right ear pain and neck pain were noted with unremarkable physical assessment other than localised neck pain around C7 and possible pharyngitis. Script provided for amoxicillin and paracetamol and referral made for cervical spine X-ray (performed 18 [Month8] — mild degenerative changes only). There is no reference to presentation of GI or pelvic symptoms at either consultation.
9. [Ms A] attended [Dr B] on three occasions in [Month9] … On 9 [Month9] symptoms of constipation (six days) and epigastric bloating are recorded with findings of no distress, abdomen soft, N bs, no guarding or rebound … Diagnoses made of constipation and possible gastritis and prescriptions for pantoprazole and lactulose syrup provided. On 15 [Month9] notes state only: epigastric bloating, seen in person with script provided for domperidone. On 20 [Month9] [Ms A] attended [Dr B] with symptoms of three days’ dysuria, possible slight haematuria and urinary frequency. She was also constipated and had been using Microlax enemas obtained over-the-counter from the pharmacy. She had also developed an itchy papural rash 2–3mm upper abdomen noted to be blanching when viewed. She was afebrile (T 35.9) and provisional diagnosis was made of urinary tract infection, MSU sent for culture (results suggestive of contamination with pyuria, epithelial cells and mixed growth) and empiric antibiotics prescribed (cefaclor). Prescriptions were also provided for Microlax enemas, paracetamol, antihistamine and steroid cream
10. [Ms A] next attended [Dr B] on 6 [Month10] … Notes include:
Pandemic, GP in PPE, seen in under cover carpark. 2 weeks ago abdominal bloating epigastric and lower abdominal pain been constipated since 9 [Month9] treated with lactulose and pantoprazole 20mg/day, microlax enema. Came back today 2 day hx vomiting and abdominal distension and L lower abdominal pain and epigastric pain, passing small pellets, no diarrhoea no fever no dysuria. 10 [Month3] normal CT colonoscopy
o/e temp36.8c mild distress, distended abdomen epigastric and L lower abdominal tenderness, no obvious masses, \bp 140/70, P92/min
abdominal distension ? subacute bowel obstruction ? from constipation, previous C section 1998
[Dr B] referred [Ms A] acutely to the [Health NZ] surgical service.
11. [Ms A] was admitted to [hospital] on 6 [Month10]. Discharge summary notes history as: 61 year old lady who presented with 2/7 history of abdominal pain. Intermittent pain worsening in the last few days on a background of 2 years of bloating/constipation and weight loss and poor appetite. Seen by the GP 2/52 with abdominal pain and bloating. Epigastric and lower abdominal pain worsening. O/E — soft abdomen with generalised tenderness, no signs of peritonism. Further investigations were undertaken and CT scan report dated 7 [Month10] concludes: A large multiloculated cystic mass in the pelvis 14x12x12cm, likely of ovarian origin with widespread omental/peritoneal involvement, hepatic invasion and large volume of ascites. This most likely represents an ovarian cystadenocarcinoma. Subtle nodular pleural thickening in the left hemithorax may reflect early pleural disease. [Ms A] subsequently underwent peritoneal biopsy (8 [Month10]) and further biopsy on 2 [Month11] with histology report showing tumour of Mullerian origin but difficult to further characterize — possibly endometroid and of mixed grade. A large amount of ascites was drained on 22 [Month10]. Following MDT review it was decided [Ms A] was not a candidate for surgery and she was offered chemotherapy which she initially declined but to which she then consented. Disease progressed following three cycles of cisplatin which was then changed [4 months later] to paclitaxel and later to gemcitabine following further disease progression. However, despite chemotherapy the disease could not be controlled and [Ms A] died a month or so following change to supportive care only.
12. While it is clear there were deficiencies in the referral processes at [Health NZ], there may be some significant deficiencies in GP management related primarily to:
- tracking of an urgent referral and steps taken to ensure timely review in this regard
- apparent failure to perform further tumour marker tests and arrange gynaecology re-referral as recommended by [Health NZ]
- multiple missed opportunities to question [Ms A] regarding the status of her ultrasound and gynaecology reviews
However, I do note the [Health NZ] HealthPathways does not refer to the need to check tumour markers other than CA-125 in patients with suspected ovarian cancer[41], and there is some rationale to referring for ultrasound and gynaecology review concurrently to try and avoid cumulative waits for both services. The RNZCGP Foundation Standard[42] notes a practice should effectively manage internal and external clinical correspondence and must have: a documented clinical correspondence and investigations policy and procedure covering how to manage and track:
- laboratory results
- imaging reports
- significant investigations
- clinical correspondence
- urgent referrals
Further background on the issues associated with management of clinical correspondence and referrals in primary care can be found in the 2016 RNZCGP Policy Brief “Managing patient test results”.[43]
Addendum 18 July 2023 — response received from [Dr B] 1 October 2022 is incorporated (bold) into the sections below.
13. I recommend [Dr B] is asked to provide a response to include any general comments he has on his role in the management of [Ms A] between [Month3] and [Month10] but in particular:
(i) What information or requests did he receive from [Health NZ] in response to the ultrasound and gynaecology service referrals he made on 17 [Month3] (you might provide him with the [Health NZ] comments in this regard) and what actions did he take in this regard?
CT colonography report was received on 17 [Month3] with referrals for urgent ultrasound and urgent gynaecology review sent the same day. Acknowledgement of receipt of the ultrasound referral was received at 1744hrs on 17 [Month3]. [Dr B] states that later on 17 [Month3] I also received an email from the gynaecology clinic requesting tumour marker blood tests Ca 125, CEA, ca19-9. On the same day, [Dr E] sent a letter to me stating the lower bowel is clear of pathology and suggested a pelvic ultrasound and a gynaecological clinic referral (both of which had already been done). [Dr B] acknowledges he requested only CA 125 and believes he felt the other tumour markers were redundant as there was no suspicion of gastrointestinal cancer (CEA) or pancreatic cancer (CA 19-9). The CA 125 result was copied into the gynaecology service as requested.
(ii) What discussion did he have with [Ms A] regarding the likely time frame for her scan and gynaecology review and what to do if she did not hear from [Health NZ] for either intervention?
[Ms A] was informed of the CT colonography findings on 17 [Month3]. She was told she required urgent ultrasound scan, blood tests and gynaecology appointments and these were being arranged. [Dr B] states: I discussed with [Ms A] the likely timeframe for her scan would be several months and advised her to seek medical attention if she experienced gynaecological symptoms such as abnormal vaginal bleeding, pelvic pain, and inform me if she had not heard from [Health NZ] … At the time of the referral, [Ms A] was verbally reminded to inform our clinic if she had not received notification from [Health NZ] within 4–8 weeks, also she could ring the hospital reception to check herself on the progress of the referral.
(iii) What steps were taken to track the urgent referrals and why did these steps apparently prove ineffective?
In addition to the verbal advice provided as noted above, the abnormal CT result was kept unfiled to keep it in view. [Dr B] states: During [Ms A’s] visit on 2 [Month5]. I enquired and was alerted that she had not received any ultrasound appointment from [Health NZ]. I ask[ed] my receptionist to contact the radiology department. She was told a referral had been received and there was a long waiting list, they could not say when the appointment would be, but they will contact the patient directly. This message was conveyed to … [Ms A]. My understanding was that the gynaecology clinic appointment would proceed once they had received the ultrasound report. I was aware that the gynaecology specialist had already seen the initial CT colonogram report and thought that if they had considered that [Ms A] needed to be seen urgently, (as I had requested) that they would have organised this. There was no formal task reminder set as [Dr B] believed he had confirmed the ultrasound scan was scheduled and that a gynaecology appointment would be provided once the scan result was available. Since the events in question, he has altered his practice which is now to set a task reminder for significant results/referrals even after the hospital acknowledged the receipt of the referral and the patient was on the waiting list, Set a recall, Verbally remind the patient to contact the clinic if she/he had not heard from [Health NZ] within 4–8 weeks, the patients are given a phone number to ring the hospital reception to check themselves on the progress of their referral. I also keep abnormal results unfiled in the inbox to keep them in daily view until they have been actioned.
(iv) Please clarify whether you were aware or discussed with [Ms A] the status of her ultrasound and gynaecology referrals at any of the multiple consultations undertaken between [Month3] and [Month10].
[Dr B] states the option of private ultrasound referral was made but [Ms A] was not in a position to afford this service. There was no public funding available for community-based ultrasound. [Dr B] states he was under the impression there would be a lengthy wait for the scan and was aware of recent radiographer strikes contributing to the delay, and [Ms A] was aware of the likely wait.
(v) Please provide the following documentation:
- A copy of your practice policy on management of clinical documentation including referrals
The practice policy has been reviewed and is fit for purpose. Use of the Task Manager is recommended to follow up hospital and specialist referrals where significant pathology is suspected with patients given verbal advice regarding expected timeframes and what to do if the time frame is exceeded.
- A sequential copy of clinical notes (A4) from [Month3] to [Month10] rather than the individual consultation notes already supplied (Reviewed — no new information)
- A copy of any documentation received from [Health NZ] during [Month3]
14. Comments
(i) I believe [Dr B’s] action in completing concurrent urgent ultrasound and gynaecology referrals on 17 [Month3], as requested by [Dr E], was reasonable. It appears [Ms A] was appropriately informed of the situation and the option of private ultrasound referral was provided. I am mildly to moderately critical [Dr B] failed to follow the specific gynaecology advice to request additional tumour markers when CA-125 was only mildly elevated. CA 19-9 can be raised in some mucinous ovarian cancers when CA-125 is normal, and CEA may also be elevated in ovarian cancer[44]. A significant elevation in any one of the tumour markers in the presence of a known ovarian mass increased the likelihood of malignancy and therefore the priority for gynaecology review would be increased. However, I have regarded the previously cited HealthPathways advice as a mitigating factor. Had the additional tumour markers been completed and raised suspicion of underlying ovarian malignancy, this would not have resolved the issue of the misdirected ultrasound referral but may have increased [Dr B’s] expectation regarding urgency of the imaging and subsequent follow-up in this regard.
(ii) The response from the gynaecology service indicated [Dr B] would need to resubmit a gynaecology referral once the ultrasound result and tumour marker results were received. The tumour marker result was copied directly to the service and there was no further communication in regard to the omitted marker results that might have prompted repeat of the blood test. [Dr B] had marked the ultrasound referral as urgent (which I believe it was) yet he did not regard a wait of up to several months for the procedure to be undertaken as unusual. I am not sure of the basis of this expectation and confirmation of expected wait times for urgent pelvic ultrasound requests [at the time of events] might be confirmed with the provider. Noting the only mildly elevated CA 125 result and the fact the ovarian mass was an incidental finding in an asymptomatic (for ovarian cancer) patient, an expected wait time (as documented by [Dr B] in his response and evidently discussed with [Ms A]) of 4–8 weeks for the procedure may not have been unreasonable, and I note at the six-week mark [Dr B’s] nurse apparently confirmed the request was “in the system” but a longer wait was expected. [Ms A] was apparently relatively asymptomatic with respect to her underlying malignancy until [Month9]. Nevertheless, unless it is confirmed by the provider that a wait time in excess of two to three months was standard for an urgent pelvic ultrasound at the time of the events in question, I would be mildly to moderately critical that [Dr B] did not make further efforts to check the status of the referral between [Month7] and [Month9]. I believe when [Ms A] presented with abdominal bloating and constipation from 9 [Month9], enquiry regarding the status of the ultrasound was certainly indicated although the diagnosis of ovarian cancer was confirmed less than a month later when [Ms A] developed more acute abdominal symptoms, and ultrasound in [Month9] rather than [Month10] is not likely to have altered her prognosis or subsequent clinical course.
(iii) I am mildly to moderately critical that [Dr B] did not follow his practice policy with respect to use of Task Manager to track completion of [Ms A’s] ultrasound and gynaecology review although I note he has now altered his practice in this regard. However, effectiveness of the recall system relies on expectation of completion time for the task in hand which then influences the time at which the task becomes overdue. For example, had [Dr B] expected a four month wait for the ultrasound to be completed a recall would be set for this period with the task not being overdue (in this case) until towards the end of [Month7]. This might have resulted in the ultrasound being completed a few weeks earlier than it was. An additional issue is when a task should be regarded as completed. While I think it is a reasonable expectation that [Health NZ] has robust processes in place to ensure that once receipt of an electronic referral has been confirmed to the referrer, the referral will be triaged and managed appropriately, it is evident from multiple cases I have reviewed that this is not the case and referrers should be encouraged to maintain the referral as incomplete until the service being requested has been undertaken. While this is somewhat burdensome on primary care, it provides an additional safety
back-up which is in the best interests of the patient.
15. Addendum 19 December 2023
I have reviewed a response from [Dr B] to the preliminary advice above and an independent report from senior specialist GP [Dr G] in support of [Dr B’s] management. My comments are:
(i) I agree entirely with [Dr G’s] observations (from a primary care perspective) regarding the management of [Dr B’s] quite appropriate gynaecology and ultrasound referrals by [Health NZ], and the … actions in declining an appropriate referral when, in my opinion, adequate information had been provided or would be available (via forthcoming blood and ultrasound results) to enable appropriate prioritizing of the referral. If the gynaecology service was aware at the time of the events in question that a pelvic ultrasound ordered by a GP and which accurately outlined the clinical scenario presented by [Ms A] was unlikely to be undertaken for 3–4 months, deferring a first specialist appointment until this imaging had been undertaken without taking steps to ensure timely imaging was available appears quite unreasonable. There appears also to be a complete lack of understanding by [Health NZ] of the burden placed on primary care when resubmitting of already completed referrals is required, and in the requirement to track referrals to secondary care, essentially because of the unreliability of secondary care processes.
2. I agree with [Dr G] that the main reasons for the delay in [Ms A’s] cancer diagnosis are related to process failures or inefficiencies in secondary care rather than oversights on the part of [Dr B]. Nevertheless, while it is frustrating for primary care clinicians to have to track referrals to secondary care or provide updated referral information when relevant to ensure management is undertaken in a timely manner, in the interests of patient safety and wellbeing these actions remain important. It could be argued that it would be equally important, and a similar clinical burden, for secondary care to be required to track completion of additional tasks requested of primary care as part of the referral process. The scenario whereby a four month or unspecified “long wait” for urgent pelvic ultrasound becomes the “new normal” (as appears to be the case here based on the information available) is entirely unsatisfactory and it is difficult to see what [Dr B] might have done to expedite [Ms A’s] ultrasound referral given there was no major change in her overall clinical picture (ie. no new clinical information to present) until late [Month9] or [Month10]. I note [Dr B] did attempt in [Month5] (per his receptionist) to clarify the wait time and was apparently not given any specific indication other than a “long wait”, and no indication from radiology staff that the referral was not in fact in their system. I believe I gave these factors inadequate consideration in my initial advice.
3. I believe there remains a potential issue with [Dr B’s] failure to complete the additional requested tumour markers CA19-9 and CEA which, contrary to
[Dr G’s] assertion, do have a limited role in the diagnosis of ovarian malignancy. However, I could find no record of these markers being completed following [Ms A’s] admission to ACH in [Month10] and it is therefore unknown whether the additional markers were ever elevated or if the results would have in any way influenced the … management of [Ms A’s] referral to the gynaecology service. [Dr B] implies in his response that he was under the impression the request for the additional tumour markers (most commonly used in relation to colorectal cancer (CEA) and pancreatic cancer (CA19-9) was redundant as the CT colonography result was not suspicious for either colorectal or pancreatic cancer and, as noted in my original advice, only CA-125 is recommended in Health Pathways prior to referral of suspected ovarian malignancy. If the gynaecology service believe there is evidence to support completion of these additional tumour markers to facilitate prioritisation of the referral for a patient with an ovarian mass, I would expect such advice to be incorporated into the relevant Health Pathways or the rationale for the advice to accompany the request to the GP. Nevertheless, clarification of the reason for the request might have been sought by [Dr B] at the time if he was unwilling to order the test without such clarification.
4. As noted in my original advice, I believe given there was a suspicion of malignancy in [Ms A’s] case, it was preferable the referral was formally tracked (Task Manager) which was consistent with practice policy. However, I am not sure such tracking would have altered the outcome here given scheduling of the gynaecology first specialist appointment was dependent on receipt of the ultrasound result, and the ultrasound waiting list was an unspecified “long” period. However, I believe once three to four months had passed with no appointment evident [Month7], some of my colleagues might have again queried the wait given the circumstances (possible malignancy) and sought reassurance the imaging request had been triaged appropriately. However, I acknowledge such an action would not be required if a clinically appropriate service was being provided by [Health NZ]. [Ms A’s] management in [Month9] was undoubtedly influenced by the impact of the Covid pandemic and this factor was probably not given adequate consideration in my original advice.
5. Considering the discussion above I would like to revise the departures alluded to in my original advice:
(i) Failure to complete the additional tumour markers requested by the … gynaecology service — mild criticism
(ii) Failure to confirm after a four–five month ([Month7]–mid-[Month8]) wait when [Ms A’s] ultrasound was expected — mild criticism
(iii) Failure to formally track the referrals per practice policy — mild criticism
(iv) I believe the changes in practice referred to by [Dr B] in his response are appropriate and I have no further recommendations in this regard.’
Appendix B: Alternative expert opinion report from [Dr G]
‘Report re: [Dr B] and HDC complaint concerning [Ms A]
My name is [Dr G], MBChB (1981) Dip Obs, FRCGP (Dist). I have been a General Practitioner for 39 years. I have previously been an Honorary Senior Lecturer at National Women’s Hospital, and an examiner for the Diploma of Obstetrics and Medical Gynaecology. For a number of years, I provided expert advice to the Health and Disability Commissioner on cases concerning aspects of Maternity care and I am currently doing occasional work for the Medical Council of New Zealand as a member of a Performance Assessment Committee, investigating GP competence in cases referred to the MCNZ.
I have been asked by the Medical Protection Society of New Zealand to review this case and provide an independent opinion. I have reviewed all of the forwarded documents concerning the case.
A brief summary of events is as follows:
- On 17 [Month3] Following a referral of [Ms A] to Gastroenterology for weight loss and constipation, [Dr B] received a CT colonography report that was normal with regard to the bowel but with the incidental finding of a significant R adnexal mass 60x65x50mm — solid and lobulated and separate from the uterus. The appropriate advice from Gastroenterology, also by phone from the specialist that day, was to make an urgent referral both to Gynaecology and for a pelvic ultrasound scan. This was actioned immediately on the same day by [Dr B]. Receipt of the ultrasound referral was received later that day from the radiology department, and also on the same day came a request from the Gynaecology-Oncology triage consultant to arrange the ultrasound and perform a number of Tumour Markers. [Dr B] ordered the most relevant Tumour Marker, Ca 125, the following day and the result (which was abnormal) was forwarded to the Gynaecology clinic. The option of private referral for the ultrasound was discussed with the patient but was not affordable for her, and the concern about waiting several months for this to be done was also discussed. An interim plan was discussed should any symptoms occur, and also if she did not hear from the radiology department in due course.
- At the patients next visit for an incidental matter on 2 [Month5] [Dr B] enquired about the appointment and was informed that the patient had not heard from the radiology department. [Dr B] then instructed his receptionist to phone the department and enquire about the status of the appointment. He was advised that the appointment had been received and that the reason for the delay was that the waiting list was long. Subsequent investigation has revealed that this referral, despite being received by Radiology, was never actually entered into their system.
- [Ms A] presented subsequently with unrelated medical matters on 13 [Month6], 11 [Month7], 3 [Month8] and 9 [Month9] with constipation/gastritis. Subsequently 14 [Month9] with epigastric bloating and 20 [Month9] with a mix of constipation and some genito-urinary symptoms. On 6 [Month10] she was seen again with progressive symptoms and admitted to hospital, which ultimately culminated in her diagnosis of inoperable ovarian cancer.
I find the Gynaecology Department’s response to this referral quite concerning. In my view a request for an urgent appointment for a solid 6x5x6cm adnexal mass in a symptomatic 60-year-old women — essentially Ovarian Cancer until proved otherwise — requires exactly that, an urgent appointment. From reading Dr Maplesden’s report it seems the referral — from the hospital’s perspective — was essentially rejected pending an ultrasound report, and Tumour Markers Ca 125, CEA and Ca 19-9. This is an unusual response when it is well established that the only definitive diagnosis of an ovarian mass is through histology. Thus, although an ultrasound scan might improve a little on the existing CT scan report with regard to sensitivity and specificity for the diagnosis, in no way would it alter the fact that this woman needed an urgent laparotomy. It is a serious system failure that instead of being booked for a Priority 1 appointment, this patient was then consigned to potentially months of waiting for an USS before once again being referred, to wait once again for a clinic appointment, and wait once again on a waiting list for an operation — all of which was inevitably going to be extended by the holiday period.
With regard to the Tumour Markers it is widely recognized that in Ovarian Cancer they have very poor sensitivity and specificity, and are best utilized for monitoring disease after treatment. However, of these Tumour Markers the Ca 125 definitely has some utility, especially in post-menopausal women. This was ordered by [Dr B] on 18 [Month3], the day after it was requested, and the abnormal result forwarded to the Gynaecology clinic. I see no support in the literature for the value of CEA and
Ca 19-9 in diagnosing ovarian cancer, and I think to consider that the failure to perform these tests should in any way have impinged about the acceptance of this GP referral by Gynaecology in a timely (ie urgent) fashion, is frankly outrageous. The response to the original referral from the Gastroenterology Department, as described in Dr Maplesden’s report, provides a contrasting exemplar to the response from Gynaecology.
Taken together I think this amounts to an abrogation of responsibility by the hospital who failed not only the patient, but also the General Practitioner who had acted immediately and in good faith and was entitled to think that he had adequately performed his job. The fact that neither of his entirely legitimate urgent referrals, to both Gynaecology and Radiology, actually stuck to their targets put the GP unknowingly into subsequent medico-legal jeopardy.
The concern for [Dr B] is that after he was reassured by the Radiology department on 2 [Month5] that the referral was indeed in the system, he appears to have put the matter out of his mind in the subsequent appointments in … 2020. Perhaps he felt the matter was safely in the hands of Gynaecology, who had been privy to the CT report and the Ca 125 result. Perhaps he felt with the pressure of Radiographer strikes and then the onset of [the pandemic alert] there was nothing more he could do. Perhaps he was extremely busy and overly focused upon the presenting problems. It appears that she was presenting with a variety of symptoms and issues at these appointments, which would have occupied the whole of a 15-minute appointment, or more. With the benefit of hindsight, I may be mildly concerned that he did not revisit the issue which had been raised with the CT scan, but in the reality of current general practice, unfortunately the pressure of time in appointments often means that the patients other health issues can easily be displaced.
We must also acknowledge the wider context, that by the beginning of [Month9] General Practice unquestionably became the most stressed part of the health system in New Zealand. Whatever the explanation, [Dr B] found himself in a situation that should never have occurred.
Given the relentless pressures and severe resource constraints upon General Practice it is difficult to say what is a reasonable expectation for following up and chasing referrals that have already been acknowledged (not once, but twice). Does the GP proceed with trust and confidence in the wider medical team that he operates within, or should General Practice re-structure its systems and workload in a way that safety nets the failings of every other part of the system? Is this even possible in the current Primary Care environment?
In summary I believe [Dr B] acted as the majority of his colleagues would have done in this situation. He made an urgent referral which was seen by a specialist gynaecologist who chose not to schedule an urgent appointment. He made an urgent ultrasound referral, and having chased up the ultrasound referral to ensure it was in the system, it was reasonable for him to believe the “system” was working. Most GPs do not have the capacity to continue to chase investigation requests and having been reassured that his request had been received, it was reasonable for him to believe that it would be actioned in a timely manner. Based on my assessment of this case, my opinion is that [Dr B] provided a reasonable standard of care, and that the patient was actually let down by other providers, who were outside [Dr B’s] control.
[Dr G] 24/11/2023’
[1] On 1 July 2022 the Pae Ora (Healthy Futures) Act 2022 came into force, which disestablished all district health boards. Their functions and liabilities were merged into Te Whatu Ora|Health New Zealand (now called Health New Zealand|Te Whatu Ora).
[2] Dr B is the sole general practitioner and director of the practice.
[3] Relevant months are referred to as Month1–Month11 to protect privacy.
[4] Examination of the lining of the bowel (colon or large intestine).
[5] A scan to produce detailed images of the large intestine (colon) and anus (rectum).
[6] The presence of bright red blood during or after passing a bowel motion.
[7] An abnormal growth or enlargement in the pelvis or lower abdomen.
[8] The risk of ovarian cancer increases with age, and primarily it affects people who are post-menopausal. See: https://bpac.org.nz/2023/ovarian-cancer.aspx.
[9] An abnormal growth that develops around the uterus, usually in the ovaries, fallopian tubes or surrounding connective tissue.
[10] At the top of both referral forms, it states: ‘Referral Sent and Acknowledged on 17 Month3 [time] NZDT.’
[11] Also known as biomarkers. These are substances made by cancer cells or by normal cells in response to cancer. Different types of tumour markers correspond to a specific cancer.
[12] Cancer antigen 125 (CA 125) is a common tumour marker in patients with ovarian cancer. However, an increased CA 125 value may also be present in non-cancerous conditions (such as menstruation, pregnancy, benign ovarian cysts, and endometriosis).
[13] Cancer embryonic antigen (CEA) levels may be raised in bowel cancer, other malignancies, and non-malignant conditions (such as inflammatory bowel disease).
[14] Cancer antigen 19-9 (CA 19-9) levels may be raised in cancers of the gastrointestinal tract (such as pancreatic cancer) and in some ovarian cancers.
[15] Dr F referred to the recommendations of the CT report and Auckland Regional HealthPathways advice in making this request.
[16] Partial or total blockage of the bowel.
[17] A rare cancer of the uterus, ovary or fallopian tubes.
[18] This was documented as ‘advanced high-grade adenocarcinoma of Mullerian origin consistent with advanced ovarian cancer’.
[19] The system used to manage radiology referrals and arrange radiology appointments within the Auckland region.
[20] Software used to perform automated and repetitive pre-defined tasks.
[21] Health NZ explained that this is because the RMS is in a non-standardised text-only format and is not Health Level 7 compliant. This means that there is a lack of interoperability between systems.
[22] Health NZ stated that in 2013/2014 it sought input from software developers to mitigate potential risk and was advised against full integration, due to several factors (including cost, time, and risk of losing referrals during the testing phase, and because there was no guarantee that an integrated solution could be developed).
[23] Health NZ stated that in September 2021, there were two further incidents of referrals being received and ‘completed’, but the outcome not entered into the RIS. For example, the incident on 9 September 2021 involved a GP following up with Health NZ about a surveillance ovarian ultrasound scan request.
[24] Health NZ stated that it took between three and seven minutes to process each referral manually.
[25] Ms D told HDC that she had worked in reception and scheduling at various Health NZ facilities since 2016, including in radiology and ultrasound. She said that she had worked in ultrasound for approximately one year and six months before transitioning to CT bookings at the public hospital in Month3.
[26] Ms D stated that this included cancelling and sending invite letters, printing and loading e-referrals, sending confirmation texts to patients, clearing and booking the ultrasound waitlist, and covering the busy reception area, alongside her training in CT booking.
[27] Right 4(1) states: ‘Every consumer has the right to have services provided with reasonable care and skill.’
[28] See footnote 21.
[29] As required by relevant legislation, including the Health and Safety at Work Act 2015.
[30] Right 5 of the Code.
[31] Right 6(1) of the Code states: ‘Every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive …’
[32] It is documented that Ms A also had additional communication needs. While this was considered by clinicians during her care, it is also relevant in this context.
[33] Right 4(5) of the Code.
[34] https://bpac.org.nz/2023/ovarian-cancer.aspx
[35] Such as ‘e-triaging for high suspicion on cancer patients’ and the ‘Primary Care Management Pathway: Ovarian cyst, postmenopausal women’.
[36] Follow-up action 1 stated: ‘The Chair of the Adverse Event Review Committee to write to the Gynaecology Service to ask them to consider this report and the approach they took in the management of [Ms A’s]
e-referral.’
[37] Right 4(2) of the Code.
[38] Health NZ noted that despite this automated process, human resource may be required in some instances, such as when exceptions in the data require validation.
[39] 3 EFT.
[41] Auckland Region Community HealthPathways. Section “Ovarian Cancer Symptoms” https://aucklandregion.communityhealthpathways.org/120265.htm Accessed 19 September 2022
[42] RNZCGP Foundation Standard 2022. Manaaki Haumanu | Clinical Care. Indicator 5: Continuity of care. https://www.rnzcgp.org.nz/Quality/Foundation/Foundation_2022/Manaaki_Haumanu___Clinical_Care/Quality/Foundation_2022/Indicator_5_Continuity_of_care.aspx?hkey=0f596765-0ec8-4463-9300-a1980be532bc Accessed 19 September 2022
[43] https://www.rnzcgp.org.nz/gpdocs/New-website/Advocacy/PB6-2016-Apr-Managing-patient-test-results.pdf Accessed 19 September 2022
[44] https://bpac.org.nz/2023/tumour-markers.aspx Accessed 18 July 2023