Under-dosing of chemotherapy in ten patients with acute myeloid leukaemia reflected a series of significant failures in clinical governance at the Royal Adelaide Hospital haematology unit and a lack of adequate knowledge, skill, care and judgment by some clinicians, a formal review of the episode has concluded.
The review recommended that the CEO of the Central Adelaide Local Health Network consider referring clinicians to AHPRA.
Professor Villis Marshall, chair of the board of the Australian Commission on Safety and Quality in Health Care, led a panel of six reviewers.
They were appointed after adoption of a non-standard chemotherapy protocol incorrectly incorporated daily, rather than twice-daily, cytarabine infusions on days 1, 3 and 5 as part of consolidation regimens for AML patients.
Five patients at the Royal Adelaide Hospital and another five at Flinders Medical Centre received the incorrect dose.
Clinical governance issues identified by the review included failure to follow routine clinical processes and procedures for developing, reviewing and publishing chemotherapy protocols; failure to advise patients that the protocol was non-standard and required approval from the relevant committee and informed patient consent; and failure to provide adequate clinical supervision to nursing staff administering cytarabine.
In addition, some clinical staff did not comply with SA Health incident management and open disclosure policies by failing to report and lodge the incidents, conduct timely and appropriate open disclosure with patients and provide an immediate clinical response to patients who had been under-dosed.
The panel recommended actions to ensure all staff were aware of incident management and disclosure policies, strengthening of clinical governance systems, and better procedures for revising and implementing chemotherapy protocols.
The dosing errors occurred from July 2014 to January 2015. Although patients were informed in February or March 2015, they could not recall receiving any further advice until a media announcement was made in August.
“Some patients felt that the way they received the initial information regarding the under-dosing could have been improved,” the report said.
“In some cases it was unplanned, tacked onto an existing appointment, abrupt, not always delivered by a consultant, delivered when they were unwell, delivered without written advice or planned follow up, and not supported by counselling (psychological) or care (social) or a dedicated service to continue to discuss options.
“Patients…did not always experience a sense of empathy, care or apology but one of defensive explanation and lack of individual focus.”
The error arose when the new protocol was being written and distributed, but one patient noted that to call it simply a ‘typo’ was to trivialise the implications, which could involve a suboptimal clinical response.