Making Submissions on Regulatory Judgments on a stage 2 inspection report - Standard Operating Procedure Effective February 2018
1. Procedure This procedure outlines how and in what circumstances a provider1 1 can make a formal submission to challenge a regulatory judgment arising from an inspection prior to the stage 3 inspection report, which is published on HIQA website. 2. Scope Each inspection report goes through three main stages as they are prepared for publication: Stage 1 inspection report: Draft report at feedback stage Stage 2 inspection report: Draft report that has completed the feedback stage Stage 3 inspection report: Final report released for publication This submission procedure applies to all stage 2 inspection reports relating to inspections of designated centres for older people and children and adults with disabilities, children s residential services including the detention centres, foster care, child protection services and healthcare services. Such inspection reports may relate to monitoring inspections, follow up inspections and inspections relating to registration applications or renewals. Providers should remember that inspectors may look at any aspect of the service on inspection. In the course of their regulatory and inspection work, inspectors make judgments on an ongoing basis as to the governance leadership and management, the quality and safety of services and the degree to which services comply with relevant nationally mandated standards and regulations under the Health Act 2007 as amended, the Child Care Act 1991, the Children s Act 2001. 1 Includes intended provider and registered provider under the Health Act 2007 and services providers under The Child Care Act 1991, S.8 the Health Act 2007, the Children s Act 2001 or the person in charge, with the full knowledge and consent of the registered provider in the case of a designated centre.
Inspectors base their judgments on all the available relevant information, using their professional judgment. Inspectors do not need to reference, in the inspection report, all of the information obtained. This procedure references the inspection report at stages of development; (1) Stage 1 Inspection Report A stage 1 inspection report is issued to the provider following an inspection. The issuing of a stage 1 inspection report includes the Feedback Process. Preliminary findings will have been given during the close-out meeting. The provider can at this stage return the feedback from which includes any factual accuracy detail along with feedback on receipt of the stage 1 inspection report. It is important that in the first instance the provider should engage with the lead inspector to discuss their specific concerns or queries they may have regarding the judgments in this stage 1 inspection report. This can be completed by phone and/or email. (2) Stage 2 Inspection Report A stage 2 inspection report is issued to providers on completion of the Feedback process. (3) Stage 3 Inspection Report A stage 3 inspection report has taken into consideration any decisions of the Submissions Decision Panel (should a submission be received) and is issued to the provider prior to publication. This procedure describes the pathway open to providers at the stage 2 Inspection Report where the provider believes that they have exhausted all local avenues for review as part of the Feedback Process and that the provider believes that the judgment(s) 2 contained in the stage 2 inspection report are not based on the evidence made available to inspectors at the time of the inspection or the judgment(s) are disproportionate to the evidence reviewed. 2 Judgments mean complaint, substantially compliant or not complaint and the associated risk rating. An appeal on regulatory judgments does not include feedback on the body of the report or factual accuracies. They should be dealt with at Stage 1insepction report feedback process
As part of this procedure, providers may submit comments, evidence or descriptors of circumstances that supports their case as to why the judgment made in the stage 2 inspection report are not based on the evidence made available to inspectors at the time of the inspection or the judgment(s) are disproportionate to the evidence reviewed. 3. Out of Scope Any submission made without first completing the feedback, submitting an compliance plan and receiving the stage 2 inspection report Any commentary not related to the judgments in the stage 2 report. Any written representation made by a provider to a notice of proposal to register, renew registration, refuse registration, cancel registration, attach, remove or vary a condition of registration 3 Any matter relating to the conduct of inspectors 4 Any matter previously dealt under the Authority s complaints procedure Any matter considered to be vexatious 5 in nature Any matter about which a group of service providers or their representative body have an issue of general concern 6. Any matter relating to a third party who believes they are adversely mentioned in an inspection report, for example, a visiting health professional 7 3 These matters will be dealt with under the HIQA policy for managing representations made under section 54(1) of the Act. 4 These matters will be processed under the Authority s complaints procedure. 5 Office of the Information Commissioner, Date of Decision: 16.05.2006, Reference: 050364. Vexatious, where a compliant has been made in bad faith or forms part of a pattern of conduct that amounts to an abuse of process (or an abuse of the right of access) 6 These should be raised directly with the Chief Inspector in writing 7 Any person who believes themselves affected in this way should raise the matter directly with the inspector who is responsible for compiling the report
Any matter which is the subject of an independent inquiry or legal proceedings Published reports. 4. Making a submission on regulatory judgments Once providers have received a copy of the stage 2 inspection report, they have 10 working days to submit a formal submission using the form available on the website. 5. Procedure steps 5.1 Service Provider Submission The submission should be made using the Submission FORM available on the website and sent to the Chief Inspector/ at chiefinspector@hiqa.ie or by post to: Chief Inspector/ Health Information and Quality Authority, Unit 1301, City Gate, Mahon, Cork, T12 Y2XT. Only submission made on this form will be considered. The Person making the submission should outline the particular regulatory judgment(s) in question. Relevant evidence supporting the provider s assertion should be provided. Information contained in the submission will only relate to the regulatory judgments. No personal identifiable information should be included.
5.2 Chief Inspection/ Review Once a submission is received the inspection report will not be progressed to the publication stage until the process has been exhausted. Should the Chief Inspector/ not be satisfied that the case holder and inspector manager have exhausted the feedback process and local engagement the matter will be referred to the Feedback Process. An acknowledgement letter will be issued to the provider within 10 working days of receipt of a submission, including the Chief Inspector/ s decision on formation of a Submission Decision Panel or referral back to inspector and inspector manager to review the feedback process. 5.3 Submissions Decision Panel The Chief inspector/ will appoint a chairperson who will convene the A Submission Decision Panel to consider the matters raised. The panel will consist of; The Chairperson A member of the Regulation Directorate not directly involved in regulating the centre in question, usually a Senior Manager within regulation. The following staff will present the relevant background to the Panel: Lead Inspector and any supporting inspector(s) (if required) Line Inspector Manager Depending on the facts and circumstances of the submission, other relevant staff, including the Authority s legal adviser, may be requested to attend and/or to provide information to the Panel to aid in its deliberations. A letter detailing the decisions of the Panel will be issued by the Chief Inspector/ to the provider within 30 working days of receipt of the submission. The stage 3 inspection report will be then processed to the publication process following the issue of the letter containing the Panel
Decision(s). If regulatory judgments or inspection report text is amended, the case holding inspector will issue, for information, the stage 3 inspection report. At this stage, the provider cannot make a feedback return as the decision of the panel is final. Where it is deemed that more time is required by the Panel to reach a decision the Chairperson will within 20 days of receipt of the appeal, write to the provider advising them of the delay. Where there is persistent delay, the Chairperson will provide updates every 20 working days to the provider or person making the appeal. 5.4 Referral to Feedback Process On the decision of the Chief Inspector/, the inspection team will follow the feedback process which will include review of the service provider feedback form return, any other feedback received and direct engagement with the service provider. The inspection team will conclude the feedback process within 10 days and issue a Stage 2 inspection report to provider on day 10. The provider has on this final occasion 5 days to make a submission. 6. Records Records created as a result of using this procedure should be used and stored in line with the Authority s policy on records management. 7. Learning The Head of Regulatory Practice will produce and submit to the Chief Inspector/ reports of all decisions and identified learning opportunities. The Head of Children s services, Healthcare, Deputy Chief Inspectors, will utilise the findings from each decision and develop (if appropriate) individual and team learning action and timed implementation plans.
The Head of Regulatory Practice Development will utilise the decisions to inform system wide regulatory staff learning and development programmes.
Appendix 1 Submissions on Regulatory Judgements Standard Operating Procedure 10 Days Yes Feedback Process on Stage 1 Inspection Report Stage 2 Inspection Report issued to Provider Submission Form 01 received (via chief inspector inbox) Chief Inspector/ Director of Regulation Reviews submission Refer back to Inspector & IM No Convene Submissions Decision Panel Submissions Decision Panel 10 Days Issue acknowledgement letter Feedback Process Repeat once only 10 Days 5 Days 30 Days Inspection team reviews Feedback Additional 20 Days time for decision required No Chief Inspector/ Director of Regulation Issues Decisions Letter Amendments to Regulatory judgements Yes Amendments Made Stage 3 Inspection Report issued to Provider Yes No Dotted line indicates working days Letter to advise of delay Update(s) to provider Report Published