HDC received an anonymous complaint from a healthcare provider, which alleged that several consumers at a Health New Zealand|Te Whatu Ora (Health NZ) hospital outpatient clinic did not receive their cancer medications (Bacillus Calmette-Guerin (BCG)) between December 2018 and October 2019.
At the time, BCG therapy, which is used to treat non-invasive bladder cancer, was initiated following a referral from private urology service providers. The BCG clinic ran once a week and was managed solely by one registered nurse. The nurse was responsible for clinical assessments, administering BCG therapy, administrative management, clinical coordination, communication with key stakeholders, and addressing supply chain issues associated with the BCG medication. All other aspects of urology care were outsourced to the urology service providers.
An internal audit of the public hospital’s BCG clinic was completed in September 2019. Collectively, the audit found several issues between December 2018 and September 2019 including delays and omissions in BCG administration, patients being behind on their treatment regimen, incomplete documentation, and referrals not being actioned. The audit found that up to 13 patients had been impacted by these issues. In addition, other supporting information from Health NZ revealed that there were poor medication management systems, a lack of a clear end-to-end process for managing referrals, a lack of triaging process, poor administrative systems and there were resourcing challenges within the clinic.
Health NZ stated that the audit found no cases of cancer progression in patients who were impacted by the issues found in its internal audit. Further, all patients on the BCG treatment list were brought back for a cystoscopy[1] and a review with their specialist. However, open disclosure of the audit findings to the patients concerned did not occur.
An investigation commenced by HDC found that the failures in the clinic were rooted in a lack of effective clinical governance. In particular, there was a lack of formal development of business systems when the BCG clinic was initially set up and the BCG nurse role was poorly defined and scoped. There was no staffing model, head of department, lead senior medical officer, or urology nurse specialist to support the BCG clinic. The lack of clinical governance meant that there was no clinical oversight of the demand, delivery or patient outcomes and there were no processes in place to measure the performance of the clinic.
Health NZ acknowledged that the systems and processes within the BCG clinic were not robust. Since the events, it has made a number of changes including increasing resourcing, implementing a database for tracking treatment regimens, developing a BCG administration pathway, developing additional protocols and changes to its existing policies, implementing a BCG coordination role and introducing dedicated administrative support. Health NZ also transitioned to an electronic documentation system and completed staff training around adverse events.
Findings
The Commissioner acknowledged the patients and their families who were directly impacted by these issues and is reassured that there were no adverse health outcomes for the patients involved.
The Commissioner found critical systemic failures at the BCG clinic. Poor clinical governance compromised the operational effectiveness of the clinic and posed significant risks to patient safety. This could have been avoided with proper planning and management at the clinic’s inception and with ongoing evaluation as the clinic evolved. For these reasons, the Commissioner found that Health NZ breached Right 4(1)[2] of the Code of Health and Disability Services Consumers’ Rights (the Code).
The Commissioner found that Health NZ also breached Right 6(1)[3] of the Code for its failure to provide open disclosure to its patients regarding the clinic’s systemic failings.
The Commissioner made educational comments about the nurse’s documentation practices and for her lack of escalation of challenges to senior leadership.
Recommendations
The Commissioner acknowledged the steps taken by Health NZ to improve its systems but considers that work still needs to be done. The Commissioner made the following recommendations to Health NZ:
-
- engage an independent clinician with knowledge of BCG therapy and nurse-led clinics to review the BCG clinic’s systems, including the referrals management process, medication management, documentation practices, training and orientation provided to BCG clinic staff, leadership structure, operational effectiveness and audit framework;
-
- review its open disclosure policy and provide further training to staff;
-
- develop a BCG clinic nurse position description; and
-
- follow up with urology service providers to ensure there is a clear framework for communication of referrals.
In addition, the Commissioner recommended that the registered nurse reflect on the deficiencies in the care identified in this case in relation to documentation and escalation of concerns, and provide a written report to HDC outlining any changes to her practice.