Advisory D25/03: Assessment requirements of digital mental health service providers post significant clinical or technical governance review

Advisory details

Purpose

To describe the requirement for accrediting agencies to examine external and non-routine internal reports of reviews and investigations into significant safety and quality issues, clinical or technical governance, or safety breaches as part of a digital mental health service provider’s accreditation assessment. 

Issue

This advisory relates to external and internal reports into safety and quality issues, clinical or technical governance, or safety breaches which are described in this advisory as major safety and quality reports. 

In scope are reports on reviews, adverse events, failures in governance, coronial and sentinel event investigations, cluster reviews, Safe Work Reports, or reports from inspections, such as licensing, or Office of Chief Psychiatrist announced or unannounced inspections. Also included may be external reports that apply across multiple organisations where the recommendations apply directly to the health service organisation being assessed.

Out of scope are routine safety and quality reviews such as internal root cause analysis or incident reports and reports that do not require health service organisations or facilities to undertake any additional reviews. These reports may be viewed as part of the assessment of NSQDMH Action 1.10 Risk Management and NSQDMH Action 1.11 Incident Management Systems and Open Disclosure.

Requirements

1. Accrediting agencies must formally request information from the digital mental health service provider on major safety and quality reports, which may include reports commissioned by the relevant regulator, completed since the last assessment and/or any other relevant review currently underway. Requests may include:
   1. Terms of reference or scope of the review
   2. Commencement and completion date
   3. Recommendations from the review
   4. Executive summary
   5. Actions taken to implement report recommendations.
2. Where digital mental health service providers provide accrediting agencies with information on external reports, accrediting agencies are to forward that information to its assessors and have that information considered at assessment.
3. Where the relevant regulators provide accrediting agencies with information on external reports, accrediting agencies are to forward that information to its assessors and have that information considered at assessment.
4. Assessors are to seek an update at the commencement of the accreditation assessment of reviews in progress to determine if any safety and quality issues have been identified that warrant close inspection during the accreditation assessment.
5. Major safety and quality reports prepared under qualified privilege may be subject to privacy and confidentiality legislative obligations.
6. Where reports are lawfully able to be provided, assessors are to examine the information provided during the accreditation assessment. Major safety and quality reports are to be reviewed are not to be circulated, distributed or quoted.
7. Assessors are not to re-prosecute the review process but must seek evidence that:
   1. Recommendations from the report have been considered, and an action plan developed
   2. The action plan has been endorsed and monitored by the appropriate level of governance
   3. The actions are being progressed as per timeframes in the action plan
   4. All safety and quality systems identified as underperforming or needing improvement in the major safety and quality reports are:
      1. In place and being used or being developed
      2. Monitored by the organisation
      3. Regularly evaluated for their effectiveness
      4. Reported to the governing body.
8. Assessors are to seek an explanation from the digital mental health service provider where action has not been taken.
9. Assessors are to rate as ‘not met’ relevant actions in the NSQDMH Standards where recommendations from major safety and quality reports are not being reasonably progressed, or there is no evidence the digital mental health service provider has given due consideration to their implementation.
10. Upon review of a digital mental health service provider’s final accreditation report, relevant regulators should advise the Commission if they are aware that a major safety and quality review has been completed since the last assessment but was not provided to the accrediting agency or assessors at the time of the assessment.