Names (except the advisor) have been removed to protect privacy. Identifying letters are assigned in alphabetical order and bear no relationship to the person’s actual name.

Introduction

Case 1 — background

Case 2 — background

Cases 1 & 2 — other information

Responses to provisional opinion

Case 1 opinion: Introduction

Case 1 opinion: Mr C — breach

Case 1 opinion: Dr D — breach

Case 2 opinion: Introduction

Case 2 opinion: Mr C — breach

Case 2 opinion: Dr D — breach

Cases 1 & 2 opinion: Radiology service — other comment

Changes made since events

Recommendations

Follow-up actions

Appendix A: Independent clinical advice to Commissioner

Introduction

1. This report is the opinion of Rose Wall, Deputy Health and Disability Commissioner, and is made in accordance with the power delegated to her by the Commissioner.
2. The report discusses the care provided to two separate consumers, Mrs A and Mrs B, during their pregnancies. The cases highlight the importance of health professionals adhering to clinical guidelines and maintaining the required standard of clinical practice to mitigate the risk of error. 
3. On 18 May 2022 Mrs A submitted a complaint to this Office advising that through multiple ultrasound scans radiologist Dr D failed to identify the signs of congenital pulmonary airway malformation[1] (CPAM). The multiple scans were performed by sonographer Mr C. In Mrs A’s 36-week scan to check her baby’s growth, a different radiologist identified CPAM. Mrs A was referred urgently to the Maternal Fetal Medicine (MFM) Clinic, where a specialist advised her that if the CPAM had been identified when it was first noticeable on the ultrasound scans at 20 weeks, the subsequent interventions would likely have been less invasive and more healthy lung tissue could have been saved. Following an unsuccessful attempt to drain the fluid from the cystic thoracic masses in utero, Baby A was born via Caesarean section, after which he required multiple surgeries, including the complete removal of his right lung.
4. On 6 April 2023, Mr and Mrs B submitted a complaint to this Office advising that through multiple ultrasound scans of their twin pregnancy, Mr C and Dr D failed to identify signs of renal agenesis.[2] At 31+2 weeks’ gestation Mrs B went into pre-term labour, following which Twin 1 was diagnosed with renal agenesis through multiple tests, scans, and blood samples. In their complaint, Mrs and Mr B advised that there was evidence of total renal agenesis from the 20-week scan onwards. Sadly, Twin 1 passed away three days after birth.
5. This Office identified that the same combination of sonographer and radiologist working at the radiology service were performing and reporting on the ultrasound scans in question and, therefore, the following issues were identified for simultaneous investigation:

• Whether Mr C, Dr D and the radiology service provided Mrs A with an appropriate standard of care in 2021 and 2022.

• Whether Mr C, Dr D and the radiology service provided Mrs B with an appropriate standard of care in 2022 and 2023.

6. The parties directly involved in the investigation were:

Mrs A                                                                    Consumer/complainant

Mrs B                                                                    Consumer/complainant

Mr C                                                                      Individual provider/sonographer

Dr D                                                                       Individual provider/radiologist

Radiology service                                             Group provider

7. The following people are also referred to in the report:

Dr E                                                                       Radiologist

Dr F                                                                       Consultant obstetrician

8. Due to the concerns about Dr D’s and Mr C’s competence, the Deputy Commissioner made a referral to the Medical Council of New Zealand (MCNZ) and the Medical Radiation Technologists Board (MRT Board) pursuant to section 59(4) of the Health and Disability Commissioner Act 1994.
9. As part of the investigation, a radiologist, Dr Rachael McEwing, was asked to undertake a blind review of the imaging and referrals for each case and to report on each scan as she would in her role as a radiologist (see Appendix A). Dr McEwing had no knowledge of the outcome of either case.
10. The role of a sonographer is to acquire the appropriate images and biometry, to complete a worksheet detailing patient information and biometry, and then to record normal and abnormal findings. This information is sent to the radiologist, and the radiologist has ultimate responsibility for reporting the images and data accurately.
11. The role of a radiologist for routine obstetric scans is to ensure that appropriate data and images are obtained, and then to report on the images and data accurately.
12. The requirements of obstetric ultrasound scans are specified in the New Zealand Obstetric Ultrasound Guidelines (the Guidelines),[3] and include image and measurement requirements for each individual scan. As the baby grows, the complexity and specifics of measurements and images increases.
13. Whilst Dr McEwing is not a peer of Mr C, because the radiologist’s role includes ensuring that appropriate images are obtained, I consider that it is within her scope to make statements on Mr C’s images.

Case 1 — background

14. Mrs A became pregnant in 2021 and had a dating scan.[4] The dating scan was performed by sonographer Mr C and reported on by radiologist Dr D. Dr D reported a single live embryo with a gestational age of 9+5 weeks. Mrs A’s uterus was reported as retroverted.[5] The gestational sac[6] was reported as normal with no pelvic abnormality noted.
15. At 12+5 weeks’ gestation, Mrs A had her second ultrasound scan — the nuchal translucency (NT) scan.[7] The NT scan was also performed by Mr C and reported on by Dr D. The findings in the report identified this scan as acoustically challenging,[8] but Dr D reported no fetal abnormality, with no abnormality seen in the maternal pelvis, and he concluded that the fetal size was consistent with the previously identified estimated date of delivery (EDD).
16. At 19+5 weeks’ gestation, Mrs A had her third ultrasound scan — the anatomy scan.[9] The anatomy scan was also performed by Mr C and reported on by Dr D. Dr D reported that the measurements obtained during the anatomy scan were normal, but that due to the position of the fetus, not all required measurements could be obtained, and therefore a follow-up anatomy ultrasound scan was scheduled.
17. The follow-up scan to obtain the remainder of the measurements was performed when Mrs A was 21+5 weeks’ gestation. The follow-up anatomy scan was also performed by Mr C and reported on by Dr D.
18. Dr D reported the anatomy scan as complete from the additional images obtained at this follow-up appointment. Specifically, no abnormality was found or reported on in the aortic arch (AA) or descending aorta (DA), the placenta was noted to be posterior and clear, the liquor volume was reported as normal, and no pelvic abnormality was found.
19. Mrs A had a routine growth scan[10] performed by a sonographer and reported on by radiologist Dr E at the radiology service. At this time Mrs A was 36+2 weeks’ gestation. Dr E identified multiple cystic lesions in each hemithorax,[11] with the largest measuring 30 x 32 x 46mm. The baby’s heart was displaced and compressed by the cystic lesions, making it difficult to assess.
20. Dr E made a prompt referral to the MFM unit at the public hospital for assessment and notified Mrs A’s ultrasound referrer and lead maternity carer (LMC) of the cystic lesions identified in the most recent ultrasound.
21. Mrs A’s clinical records held by Health New Zealand|Te Whatu Ora (Health NZ) document that Mrs A was assessed by the MFM Clinic urgently due to the cystic lesions, which were suggestive of severe CPAM.
22. Immediately after the assessment, Mrs A was admitted to the maternity ward under obstetric consultant Dr F. CPAM was confirmed through an additional ultrasound scan during this admission. An attempt was made to drain the fluid from the cystic thoracic masses, which were considered macrocysts[12] due to their size. However, the fluid reaccumulated quickly. Mrs A’s clinical records document:

‘…: Large macrocystic CPAM — invading entire right lung field. Admit overnight, steroids x 2, NICU[13] aware, Review …, fetal drainage done in utero ….

…: Seen by [Dr F] … & the fetal lung cysts had reaccumulated overnight. CPAM dominates the R lung.’

23. Mrs A was discharged with an appointment for a further ultrasound scan and follow-up at the MFM clinic with Dr F.
24. The ultrasound scan confirmed that the fluid had reaccumulated and was dominating the fetal right lung. The CPAM macrocysts were documented as abnormally sized at 77 x 75 x 34mm. Prior to the drainage, the cysts had been measured at 55 x 26 x 36mm.
25. A decision was made to proceed to elective Caesarean section.
26. A referral for an anaesthetist explained the situation as:

‘Late referral and diagnosis of fetal CPAM at 36 weeks. Has had x 1 drainage of fetal lungs which reaccumulated in a day. NICU are aware and have seen [Mr and Mrs A]. Plan is for EL CS … at 39 weeks.’

27. Mrs A attended hospital for the scheduled Caesarean section.
28. Baby A’s birth records describe him as being born in good condition and requiring positive end-expiratory pressure (PEEP) for initial resuscitation followed by continuous positive airway pressure (CPAP)[14] respiratory support.
29. Immediately following his birth, Baby A was transferred to NICU for observation and management, and he remained in hospital for five weeks.
30. On the day of Baby A’s birth, an X-ray showed a large solid cystic lesion in the chest area. The lesion was invading the diaphragm space and causing an abnormal placement.
31. On day two post-birth, a computerised tomography (CT)[15] scan was undertaken to investigate the CPAM further. The scan showed several very large air- and fluid-filled cysts centred in the right middle lobe of the lung, causing significant distortion and herniation across the midline into the left hemithorax (the left side of the chest).
32. Baby A underwent a right thoracotomy[16] and resection of the lower, middle, and partial upper lobes. Postoperatively Baby A was intubated and required management of a pneumothorax[17] with chest drains.
33. Baby A experienced acute respiratory deterioration and required a pneumonectomy.[18] Baby A remained in NICU postoperatively and was able to breathe on his own after a few days.
34. Baby A was discharged home with Mr and Mrs A with advice on how to proceed and whom to contact if there were any problems, including respiratory problems. Regular follow-up was scheduled for neonatal/paediatric assessment and support.
35. In her complaint, Mrs A advised that the radiology service had confirmed with her LMC that the cysts were visible from the 20-week anatomy scan. Mrs A also advised that Dr F had told them that had the cysts been identified in the earlier scans, other drainage options would have been available to them. The NICU clinical lead advised Mrs A prior to Baby A’s birth that he had only a 40% survival rate due to the size of the cysts.
36. Mrs A explained that she understood that the four earlier ultrasound scans were missed opportunities to identify the CPAM, and that had it been identified earlier, the interventions would likely have been less invasive and more healthy lung tissue could have been saved.

Case 1 — radiology service response

37. In its response to this Office, the radiology service advised that following receipt of Mrs A’s complaint, Mr C and Dr D met to discuss her complaint and the misdiagnosis.
38. The minutes from this meeting were provided and record that Dr D and Mr C reviewed all Mrs A’s images and noted that the cystic mass was present on image 30 in the anatomy scan. The follow-up anatomy scan did not show the cystic mass, but it was obvious in the growth scan.
39. The meeting minutes record that both Mr C and Dr D conceded that not identifying the CPAM in the earlier scans was an error in observation. They determined that they would both need to be extra careful when reviewing images and would need to focus not only on the area of interest, but also on whether any abnormality could be seen in the outer areas, in this case in the lungs.
40. The radiology service’s response to Mrs A’s complaint also advised:

‘[Dr D] and [Mr C] reflected on their individual performance and acknowledged they both made an error in missing the fetal abnormality in the anatomy scan ...’

41. The radiology service’s response included a statement from Dr D and Mr C and an apology for the misdiagnosis of CPAM for Baby A.
42. The radiology service concluded its response with an apology from the organisation for the misdiagnosis of CPAM.

Case 2 — background

43. Mrs B became pregnant in 2022 and had a routine dating scan. The dating scan was performed by sonographer Mr C and reported on by radiologist Dr D.
44. The dating scan showed a dichorionic diamniotic[19] twin pregnancy. The uterus was reported as anteverted[20] with the positions of the gestational sacs normal and no pelvic abnormality found.
45. Mrs B had her second ultrasound at 12 weeks’ gestation. This scan (the NT scan) was also performed by Mr C and reported on by Dr D. The scan showed that the fetal size was consistent with the previously identified EDD and confirmed the multiple pregnancy with no abnormalities identified in the maternal pelvis.
46. Mrs B had her third ultrasound scan at 20+1 weeks’ gestation. This scan (the anatomy scan) was also performed by Mr C and reported on by Dr D. The scan confirmed the multiple pregnancy and EDD. Visualisation of each twin was recorded as good. The anatomy ultrasound report recorded measurements and observations of each twin’s head, face, spine and skin line, chest, heart, abdomen, stomach, kidney, bladder wall, limbs, and cord as normal and concluded: ‘No anatomic abnormality is detected.’
47. Mrs B had her first growth scan at 24+1 weeks’ gestation. The scan was also performed by Mr C and reported on by Dr D. The scan concluded that no abnormality was detected, with Twin 1 on the 48^th centile for growth and Twin 2 on the 71^st centile for growth (between the 25^th and 75^th centile is considered normal range). The anatomy was reported as ‘not repeated, but no abnormality was observed’.
48. Mrs B had a second growth scan at 28+1 weeks’ gestation, which again confirmed the EDD. This scan was performed by Mr C and reported on by Dr D. Both Twin 1 and Twin 2 were reported as transverse[21] with the head to the maternal left. Twin 1 was reported as being on the 14^th centile and Twin 2 was on the 58^th centile for growth. However, there was no mention of Twin 1 being significantly below normal range, indicating that he might be a ‘stuck twin[22]’. The anatomy was reported as ‘not repeated, but no abnormality was observed’.
49. Three weeks later, Mrs B’s LMC recorded in the clinical records that at 1.43pm she received a telephone call from Mrs B, who was attending a pre-organised obstetric clinic for anaesthetist assessment and was experiencing contractions every 5 minutes lasting 30–40 seconds.
50. At 3.36pm the LMC recorded meeting Mrs B at the delivery suite and commencing cardiotocography[23] (CTG) while Mrs B continued to experience contractions every 4–5 minutes lasting 30–40 seconds and becoming more painful. The LMC had trouble obtaining both babies’ heart rates, and the Associate Clinical Manager (ACM) attended and located these. The ACM discussed Mrs B with the Delivery Suite Manager.
51. At 4.52pm, after assessment by an obstetrics and gynaecology registrar, Mrs B was moved to the delivery suite.
52. Mrs B and her twins continued to be monitored until their delivery via Caesarean section. Twin 1 was born at 8.22pm and Twin 2 was born at 8.24pm.
53. The maternity discharge papers for Mrs B record:

‘[W]ell pregnancy until presentation for delivery. At birth (via c section) Twin 1 — taken to NICU for resuscitation and admission. Twin 2 — delayed cord clamping then admitted to NICU.’

54. On assessment after birth, Twin 1 was found to have an ‘antenatally undetected absence of kidney and bladder’ and, sadly, he passed away on day three of life.
55. In her complaint, Mrs B advised that the scans and analysis were not completed with reasonable care or skill, as there was evidence of total renal agenesia in the anatomy scan at 20 weeks’ gestation. Mrs B felt that if it had been picked up earlier, medical testing on Twin 1 could have been reduced after his birth and potentially could have reduced the trauma Mr and Mrs B experienced.

Case 2 —Radiology service response

56. In its response to Mrs B’s complaint, the radiology service provided a copy of minutes from a meeting between Mr C and Dr D when they met to discuss Mrs B’s complaint and misdiagnosis.
57. The minutes documented that Mr C and Dr D had reviewed the anatomy and all subsequent growth scans.
58. Documentation of their discussion of the review of the scans was minimal, but they agreed that the anatomy scan was difficult because of the fetal position, and that Dr D thought Twin 2’s liquor pocket was Twin 1’s, and that the lack of movement by Twin 1 was not noted in the scan.
59. The remainder of the minutes document the conversation about Mr C’s workload, a decision to take him off anatomy and twin growth scans, and that an arrangement had been made for Mr C to have additional training with the MFM unit at the hospital.
60. The radiology service’s response included a statement from Mr C in which he explained that in image 10 and 19 of the anatomy scan he had mistaken a small cystic area on the pelvis to be the bladder and renal arteries of each twin, and therefore he did not recall the patient for an additional scan, thinking he had seen the required anatomy.
61. Mr C concluded by advising: ‘I deeply regret my errors and the effect this had on [Mrs B] and her family. I again offer my sincerest apology.’
62. Dr D also provided a statement in response to Mrs B’s complaint, advising that Mr C had incorrectly labelled Twin 1’s kidney and recorded in the preliminary report that visualisation had been good, giving Dr D the (false) reassurance that the kidneys had been well visualised. Dr D advised that therefore, there was no indication to contradict or override Mr C’s findings.
63. Dr D also explained that Twin 2’s liquor pocket was mistaken as Twin 1’s and incorrectly labelled as such, and therefore it was not recognised that the reduced liquor for Twin 1 would have indicated a stuck twin, along with the discrepancies in growth size between each fetus.
64. Dr D advised that he sincerely regrets not picking up the renal agenesis diagnosis in his review and report, and he extended an apology to Mrs B and her family for the stress they have gone through.

Cases 1 & 2 — other information

65. In its response to this Office, the radiology service provided relevant sections of its procedural guidelines. This included details of the required images and measurements when a sonographer undertakes an anatomy scan at the radiology service.
66. The radiology service also provided a copy of the template sonographers are required to complete when performing an anatomy scan, which includes spaces to input the required measurement.
67. In Dr D’s response to Mrs B’s complaint, he advised that the procedural guidelines set by the radiology service had been followed by both himself and Mr C in terms of required images and measurements.
68. Following receipt of both Mrs A’s and Mrs B’s complaints, the radiology service arranged for radiologist Dr E, who is a director of the radiology service, to undertake an audit of 100 anatomy scans performed by Mr C and reported on by Dr D to ensure that no further misdiagnosis or abnormalities had been missed. Following the audit, Dr E stated: ‘I have found no misdiagnoses or cases of overlooked abnormality.’
69. The radiology service also facilitated a meeting for Dr D and Mr C to discuss each complaint to determine how the issues had arisen and what learnings could be taken from each case.

Responses to provisional opinion

70. Mrs A was provided with an opportunity to respond to the introduction and background sections of the provisional decision in relation to her complaint and acknowledged receipt of the report but provided no comment.
71. Mrs B was provided with an opportunity to respond to the introduction and background sections of the provisional decision in relation to her complaint and acknowledged receipt of the report, required clarification on some parts of the process, which was responded to, and gave no comment on the content of the provisional opinion.
72. Mr C was provided with an opportunity to respond to the provisional opinion as it related to him and his practice. Mr C acknowledged receipt of the provisional opinion, accepted the findings, including the recommendations, and provided an apology letter for Mrs A and Mrs B, which will be enclosed with their copy of this opinion.
73. Dr D was provided with an opportunity to respond to the provisional opinion as it related to him and his practice. Dr D acknowledged receipt of the provisional opinion, accepted the findings, including the recommendations, and provided an apology letter for Mrs A and Mrs B, which will be enclosed with their copy of this opinion.
74. The radiology service was provided with an opportunity to respond to the provisional opinion. The service acknowledged the provisional opinion and accepted the decision.

Case 1 opinion: Introduction

75. Mrs A had five ultrasound scans throughout her pregnancy. The first four were performed by sonographer Mr C and reported on by radiologist Dr D.
76. Overall, all reports completed by Dr D with images obtained by Mr C were reported as normal, with no concern about the baby’s development noted, and no recommendation for obstetric or MFM review made.
77. A different sonographer and radiologist performed a growth ultrasound scan at 36+2 weeks’ gestation. They identified cystic lesions within the baby’s lung, which later were identified as CPAM.
78. An immediate referral to the MFM service was made and an attempt to drain the cysts undertaken, but the fluid reaccumulated quickly.
79. Baby A was born via Caesarean section.
80. Baby A spent five weeks in NICU and underwent two surgeries, including a right pneumonectomy.
81. In Dr McEwing’s blind review of the dating ultrasound scan performed at 9+5 weeks, she noted that cardiac activity had not been documented. The Guidelines include cardiac activity in the list of minimal reporting requirements for all obstetric dating ultrasound scans. Dr McEwing also advised that the left ovary had been labelled, but it was not definitely visible on the image.
82. In the blind review of Mrs A’s NT scan performed at 12+5 weeks, Dr McEwing advised that the scan itself was incorrectly labelled as ‘NUCHAL [Mr C’s first name]’, the fetal heart was not imaged despite being reported on, and the NT measurement was technically suboptimal as there was inadequate magnification.
83. Dr McEwing provided a list of recommended fetal anatomy to be assessed during the NT scan from the Guidelines and advised that none of these structures had been imaged adequately on Mrs A’s NT scan.
84. As per the Guidelines, the anatomy scan assesses fetal biometry and anatomy, screens for structural abnormality, and establishes the placental location. Within the Guidelines there is an extensive list of the required measurements to be taken during the anatomy scan.
85. In Dr McEwing’s blind review of Mr C’s images during the first anatomy scan she summarised:

‘Views of the brain, face, abdomen, heart and extremities are very limited and non-diagnostic. No colour Doppler views have been obtained of the fetal heart.

The lower margin of the placenta cannot be ascertained on these images and low lying placenta/placenta previa cannot be excluded.

The recommendation for standard imaging within the national guideline do[es] not appear to have been adhered to.

There is an abnormal elongated fluid structure suspicious for bowel in the fetal thorax. The right hemi-diaphragm has not been imaged. Appearances are highly concerning for congenital diaphragmatic hernia (CDH).

The presence of associated choroid plexus cysts raises the possibility of a chromosomal abnormality in this fetus.

Head and abdominal measurements are above the 90^th centile.

Ideally, tertiary or fetal medicine referral should have been advised and follow up scan to complete anatomy should have been arranged.’

86. Dr McEwing included in her summary of the follow-up anatomy scan that although the study was labelled ‘Fetal Echo[24]’, none of the basic cardiac anatomy had been imaged as per the Guidelines.
87. Dr McEwing’s review of Mrs A’s ultrasound scans performed by Mr C and Dr D summarised that the images in all scans, excluding the dating scan, were suboptimal and did not adhere to the Guidelines. In addition, the fetal heart was not assessed adequately in any of these ultrasound scans, some of the recommended anatomy was not imaged as per the Guidelines, and the lower margin of the placenta was not imaged.
88. Dr McEwing concluded:

‘Appearances are in keeping with a significant structural abnormality most in keeping with a right congenital diaphragmatic hernia. Although the third trimester imaging has not clearly shown a connection between the fluid filled structures in the fetal thorax in keeping with bowel, appearances at the anatomy scan were highly suggestive of bowel. The heart is significantly displaced. The differential diagnosis includes a pulmonary cystic abnormality such as CPAM (congenital pulmonary airway malformation). Fetal Medicine or Tertiary referral would have been appropriate at the time of the anatomy scan when these findings were present.’

Case 1 opinion: Mr C — breach

89. The Australasian Society for Ultrasound in Medicine (ASUM) guidelines state that sometimes it may not be possible for sonographers to obtain adequate images, and in that event, the fact that the assessment is limited must be recorded.
90. The radiology service explained in its response that its sonographers type in a preliminary report, which the radiologist then reads and authorises. Therefore, it would be the responsibility of Mr C, as the sonographer, to flag with Dr D any difficulties faced resulting in suboptimal images when performing the ultrasound scans.
91. Dr McEwing’s independent advice is accepted for Mr C because of her knowledge, as a radiologist, of the requirements of a sonographer in terms of the standard of images obtained.
92. I accept Dr McEwing’s blind review of Mrs A’s pregnancy scans as described above — three out of the four scans performed by Mr C had suboptimal images, did not adhere to the current Guidelines, and on numerous occasions had incorrect labelling. The extent of Mr C’s departure from the Guidelines is particularly evident in the NT scan, for which Dr McEwing advised that ‘none of the required structures in the NT scan had been adequately imaged in adherence with the Guidelines’.
93. Dr McEwing’s blind review highlights that the scope and standard of imaging performed by Mr C in three of the four ultrasound scans he performed on Mrs A did not adhere to national guidelines. In my opinion, this represents a significant departure in the standard of care. I therefore find that Mr C did not provide services to Mrs A with reasonable care and skill and breached Right 4(1) of the Code of Health and Disability Services Consumers’ Rights (the Code).

Case 1 opinion: Dr D — breach

94. Radiologists practising in New Zealand have a requirement to adhere to the Royal Australian and New Zealand College of Radiologists (RANZCR) standards of practice, which under sections 5.5.1 and 17.3.5 stipulate the responsibilities of the reporting radiologist. The standards state:

‘A single named clinical radiologist is to be responsible for the supervision, interpretation and reporting of the entire study.

The responsibility for the conduct of the study and the production of the report lies with the clinical radiologist.’

95. I accept Dr McEwing’s advice that the images obtained throughout Mrs A’s ultrasound scans were suboptimal and labelled incorrectly. As per the RANZCR standard of practice, Dr D held overall responsibility for the reporting of each ultrasound scan and was required to provide the sonographer with feedback if their images were not of the expected quality or if the sonographer did not provide images as required in the Guidelines.
96. In Mrs A’s case, Dr McEwing first identified and reported on the abnormalities suggestive of CPAM in the first anatomy scan.
97. In the follow-up anatomy scan, Dr McEwing again reported further on the abnormalities.
98. Dr McEwing concluded in the blind review that MFM or tertiary referral would have been appropriate at the time of the first anatomy scan at 19 weeks and 5 days’ gestation.
99. Mr C and Dr D reviewed Mrs A’s scan and acknowledged that the cystic mass was first present in the first anatomy scan.
100. It is extremely concerning that Dr D signed off reports for Mrs A without having seen all the required images as set out in the Guidelines, and accepted images from Mr C that on multiple occasions were suboptimal or were labelled incorrectly. In my opinion, this represents a significant departure in the standard of care provided by Dr D.
101. In considering Dr McEwing’s blind review and noting the above, I find that Dr D failed to recognise the cystic mass, failed to recommend MFM for tertiary referral at the time of the anatomy scan, and signed off on reports with suboptimal images and incorrect labelling, and without viewing all the required images as set out in the Guidelines. Therefore, I find that Dr D failed to provide Mrs A services with reasonable care and skill, in breach of Right 4(1) of the Code.

Case 2 opinion: Introduction

102. Mrs B had five ultrasound scans throughout her twin pregnancy, all of which were performed by sonographer Mr C and reported on by radiologist Dr D.
103. Overall, all reports completed by Dr D with images obtained by Mr C were reported as normal, and specifically reported no abnormality having been seen.
104. Mrs B delivered her twins via Caesarean section, after which Twin 1 was found to have renal agenesis and, sadly, he passed away three days later.
105. Throughout the blind review of Mrs B’s ultrasound scans, Dr McEwing made note of the time taken on each ultrasound scan based on the timestamps on the images.
106. Dr McEwing’s blind review of the dating ultrasound scan reported the dichorionic, diamniotic twin pregnancy and summarised that technically the images were adequate, but the cardiac activity had not been documented on the images, which, as advised earlier, is a requirement of the Guidelines.
107. In the blind review of Mrs B’s NT scan, Dr McEwing reported that the images of the NT measurement were suboptimal as they were not magnified appropriately or positioned correctly. Dr McEwing advised that the fetal anatomy imaging for both twins was incomplete, and she provided a list of images and measurements that the Guidelines recommended be taken.
108. Throughout Dr McEwing’s reporting of the anatomy scan, she advised that the images were suboptimal, and in the summary, she advised that there was suboptimal visualisation of the brain, extremities, kidneys, and heart in both twins and neither bladder was imaged. Dr McEwing considered that therefore, the Guidelines had not been followed for Mrs B’s anatomy scan.
109. In the first growth scan, Dr McEwing describes the assessment as being limited and again suboptimal, noting that the kidneys had not been imaged on either twin. The bladder had been labelled as present for both twins, but it is not demonstrated clearly for either.
110. Dr McEwing’s blind review of Mrs B’s ultrasound scans summarised that as per the Guidelines, the assessment of fetal anatomy was incomplete for each gestation. In particular, she noted that the heart had not been assessed appropriately in either twin. Dr McEwing also advised that the imaging of all scans was of shorter duration than she would expect, particularly for a twin pregnancy. Dr McEwing’s conclusion included the following:

‘The bladder for [Twin 1] has not been shown on any scans despite being labelled as present.

The kidneys for [Twin 1] appeared echogenic on the anatomy scan and have not been imaged in subsequent scans.

A renal anomaly for [Twin 1] is not excluded.

Amniotic fluid assessment for [Twin 1] on the 28-week growth scan is not clear (obscured by the fetus) and may not reflect a pocket of fluid.

Obstetric review should have been recommended at 28 weeks for small gestational age [Twin 1].’

111. In its response to Mrs B’s complaint, the radiology service advised:

‘Following the complaint, [Dr D] and [Mr C] immediately conducted a review meeting and went through [Mrs B’s] scans together, reviewing all of the images and reports in detail. From this meeting, [Dr D] and [Mr C] reflected on their individual performance and acknowledged that they made an error in missing the renal agenesis diagnosis in one of the twins in the anatomy scan … and missed the “stuck twin” in the two following grow[th] scans …’

Case 2 opinion: Mr C — breach

112. I accept that in the blind review of Mrs B’s ultrasound scans, Dr McEwing identified numerous incidents where images taken by Mr C were suboptimal and did not adhere to the Guidelines and were labelled incorrectly. Specifically, Dr McEwing noted that the NT measurements were inaccurate and Twin 1’s kidneys were echogenic in the anatomy scan and not visualised in any further ultrasound scans, and the bladder of Twin 1 was not shown on any scan despite being labelled as present.
113. I appreciate that Dr D and Mr C met to discuss both incidents after the complaint for each was received. I acknowledge that discussions around Mr C’s workload occurred and decisions were made, namely to remove Mr C from anatomy and twin growth scans for the foreseeable future, to undertaken additional training/upskilling, and to consider reducing his workload.
114. Given that there is no evidence to suggest that Mr C was aware that his images were suboptimal and he did not advise Dr D of any issues faced whilst performing Mrs A’s and Mrs B’s ultrasound scans, I have significant concerns about Mr C’s skills as a sonographer, and I will follow up on my referral to the MRT Board with a copy of this report and will suggest that a competence review is undertaken.
115. Guided by the review undertaken by Dr McEwing, in my opinion there was a significant departure in the standard of care Mr C provided to Mrs B. I find that Mr C did not provide services to Mrs B with reasonable care and skill and breached Right 4(1) of the Code, because the images obtained throughout her pregnancy ultrasound scans were suboptimal and were labelled incorrectly.

Case 2 opinion: Dr D — breach

116. Mrs B had five ultrasound scans throughout her pregnancy, all of which were performed by Mr C and reported on by Dr D.
117. In the blind review of the anatomy scan, Dr McEwing reported an unusual presence and noted that the kidneys for Twin 1 appeared echogenic but had not been well assessed, and Twin 1’s bladder was not seen.
118. Dr McEwing concluded that a renal anomaly for Twin 1 could not be excluded, and that obstetric review should have been recommended at 28 weeks’ gestation for Twin 1, who was small for gestational age.
119. Dr D and Mr C reviewed Mrs B’s anatomy and subsequent growth scans and recorded that Mr C advised that the anatomy scan was difficult, but he thought he saw the fetal kidneys. Dr D acknowledged the difficulties in the anatomy scan and that there was a lack of movement for Twin 1 that was not recognised during the growth scan.
120. It concerns me that Dr D signed off reports for Mrs B without having seen all the required images or anatomy as set out in the Guidelines. In my opinion this represents a significant departure in the standard of care Dr D provided.
121. I find that Dr D did not provide services to Mrs B with reasonable care and skill and breached Right 4(1) of the Code for failing to recognise the renal anomaly for Twin 1, failing to recommend obstetric review for Twin 1’s small for gestational age, and for signing off on reports without having noted suboptimal images or seeing all required images as set out in the Guidelines.

Cases 1 & 2 opinion: Radiology service — other comment

122. As a healthcare provider, the radiology service is responsible for providing services in accordance with the Code.

Standard of care

123. I acknowledge that the radiology service had in place procedural guidelines and a template for the anatomy scan that included spaces to input the required measurements. It is concerning that Dr D considered that the procedural guidelines had been followed in terms of required images and measurements. While images may have been obtained and measurements input, as Dr McEwing has found, many of the images were suboptimal and the anatomy was not visualised adequately.
124. It was appropriate that the radiology service had in place guidelines for the images required to be obtained and a sonographer worksheet to be completed, but the responsibility then passed to Dr D and Mr C, as registered health professionals in their respective fields, to adhere to the guidelines of their professional regulatory bodies and obtain and assess the images appropriately, and for Dr D to report on them appropriately.
125. I consider that Dr D’s misdiagnoses and Mr C’s suboptimal images and incorrect labelling of scans and images were independent clinical errors and do not indicate broader systems or organisational issues at the radiology service. Accordingly, I consider that the radiology service did not breach the Code directly.

Concluding remarks

126. In conclusion, the findings from this investigation highlight failings in the standard of care provided to separate consumers by the same two health professionals. This report emphasises the importance of a scheduled maternity ultrasound scan as a principal opportunity to identify fetal developmental issues in utero. The common element in both cases was the failure of the sonographer and radiologist to maintain their respective standard of clinical practice during the performance of multiple ultrasound scans. In each case, this resulted in missed opportunities to diagnose medical issues with the developing fetus at the earliest opportunity. Understandably, this delay in diagnosis had a profound and lasting impact on the consumers concerned and their wider whānau/family. 

Audit

127. It was appropriate that following these events, the radiology service arranged an audit to consider the scans conducted and reported on by Mr C and Dr D. The audit was completed by Dr E, who is a director of the radiology service. I acknowledge that Dr E did not find any further missed abnormalities from a sample of 100 other cases conducted together. However, in my view, it would have been more appropriate for an audit of this nature to be undertaken independently by a party external to the radiology service. Therefore, I have recommended that a further audit be undertaken (see below).

Changes made since events

128. Following these incidents, Dr D, Mr C, and the radiology service implemented several changes, as outlined below.

Dr D

Ongoing education

129. Dr D:
     • 1. • Attended an online refresher course on obstetric ultrasound requirements in New Zealand.
     • Attended an RANZCR Annual Scientific meeting and the obstetric ultrasound lectures relevant to both misdiagnoses.
     • Attended all the lectures and presentations at an International Fetal & Women’s Imaging conference.
     • Attended a Wāhi Rua NZ Maternal Fetal Medicine Network Update Day and Fellows Day.
130. Dr D advised that following reflection of the incident and current workload pressure, he retired from the hospital components of his work and now is employed only in clinic work.
131. In response to the provisional opinion, Dr D advised that he is practising under a voluntary undertaking with the Medical Council of New Zealand, where all his obstetric anatomy scans are reviewed by a supervisor.

Mr C

Ongoing education

132. Mr C:
     • Attended eight webinars and reviewed four papers on multiple subjects, including in relation to obstetric ultrasound, early anatomy, and outcomes of antenatally diagnosed congenital cystic adenomatoid malformation (CCAM).[25]
     • Ceased performing anatomy and twin growth ultrasound scans.
     • Is no longer employed by the radiology service.

Radiology service

133. As a result of this complaint, the radiology service initiated morbidity/mortality meetings in which radiologists and sonographers discuss complex cases or cases with suboptimal outcomes.
134. Following receipt of the second complaint, Dr E, a radiologist at the radiology service, conducted an audit of 100 obstetric cases performed by Mr C and Dr D and found no further misdiagnoses.

Recommendations

135. I recommend that Dr D use this report as a basis for a case study presentation to his peers focusing particularly on the breaches of the Code identified, including details of the misdiagnoses. Evidence confirming the content of the presentation is to be provided to HDC within six months of the date of this report.
136. I recommend that Mr C:

1. Enter into a mentoring relationship with a senior colleague for at least one year, to review images from a collection of scans regularly to ensure that the images obtained through scans performed adhere to the requirements as per the current Guidelines, with confirmation to HDC that mentoring has occurred, and that Mr C’s images are in accordance with the current Guidelines.
2. Review the Guidelines against images taken for Mrs A and Mrs B and reflect on the departures from the Guidelines. Mr C should provide this Office with a reflection based on this review within six weeks of the date of this report.

137. I recommend that the radiology service:

1. Undertake a new audit by an external party, to consider whether any other diagnoses were missed, as well as to consider whether the images obtained were sufficient and labelled appropriately and provide the outcome within six months of the date of this report.
2. Review the current procedural guidelines and reporting templates to ensure that they are in line with the New Zealand Obstetric Ultrasound Guidelines and provide an update within six months of the date of this report.

138. Considering the issues identified in these cases, I recommend that the Medical Council consider whether a review of Dr D’s competence is warranted.
139. Considering the issues identified in these cases, I recommend that the Medical Radiation Technologists Board consider whether a review of Mr C’s competence is warranted.

Follow-up actions

140. A copy of this report with details identifying the parties removed, except the advisor on this case, will be sent to the Medical Council of New Zealand, and it will be advised of Dr D’s name.
141. A copy of this report with details identifying the parties removed, except the advisor on this case, will be sent to the Medical Radiation Technologists Board, and it will be advised of Mr C’s name.
142. A copy of this report with details identifying the parties removed, except the advisor on this case, will be sent to the Royal Australian and New Zealand College of Radiologists and placed on the Health and Disability Commissioner website, www.hdc.org.nz, for educational purposes.
143. Dr D and Mr C will be referred to the Director of Proceedings in accordance with section 45(2)(f) of the Health and Disability Commissioner Act 1994 for the purpose of deciding whether any proceedings should be taken.