Presented by: Colin Johnston, Director of Patient Safety, Medical Director

Agenda 127/10 Public Board Meeting, 30 September 2010 CQC Compliance Update Report September 2010 Presented by: Colin Johnston, Director of Patient Safety, Medical Director This report provides an update following the Q2 report to Board in July 2010 against the CQC Essential Standards of Quality and Safety. Update Since the last report, which was presented to the Trust Board in July the Trust has: Identified concerns within Outcome 10 Safety and Suitability of Premises that require notification to the CQC. The CQC will need to make a decision on what regulatory conditions/actions (if any) will be taken. The Trust is in the process of notifying the concern with the CQC clarification is awaited from the CQC local assessor. The statement of compliance is attached at appendix 1 and the Board is receiving a briefing from the Director of Strategy and Infrastructure. Director of Delivery; Russell Harrison has been identified as the Executive for Outcome 6 Cooperating with providers Director of ursing; atalie Forrest has been identified as the Executive for Outcomes 1,4,5,7 and 17. Outcome 9 Management of Medicines still has outstanding actions. Although significant progress has been made, further work is required as detailed in the actions summary below. Outcome 17 complaints recorded compliance against the deadline identified on registration. However, further review has identified an issue in relation to development, implementation and monitoring of action plans, as indicated in the action summary below. Assurance in relation to Outcome 11 Safety, availability and suitability of equipment requires review following an internal audit, which identified significant gaps in staff training on medical devices. The impact of this has been discussed at the Audit Committee, and more recently at the Integrated Risk and Governance Committee. The compliance pro forma is attached as appendix 2. The Board is receiving a separate briefing on the findings from the audit. Outcome 4: Care and welfare of people who use services Following confirmation that the Director of ursing is the Executive lead for this outcome, the process for assurance is being agreed. Initial review of the outcome suggests that there are not significant gaps that would represent a concern Conclusion The Board is asked to review the update above and the attached appendices, which provide further details of work under way to address gaps in assurance and detail of the rationale for recording a minor concern in relation to Outcome 10. The Board is asked to consider the conclusions drawn about compliance and endorse or challenge. WHHT Provider Compliance Assurance The table below provides a summary of the compliance against the CQC outcomes ticks in the column to the right (Outstanding Trust Issues to Enhance Compliance) denote that further work is in train to strengthen and enhance compliance, however the Trust remains compliant with these standards as indicated. Please note those outcomes in bold were excluded from the report reviewed by the Audit Committee with concerns about omission. Detail of these outcomes is therefore included for completeness. Please note standards leads will be asked to ensure that risks of non- compliance are added to risk registers as appropriate. 1

Section The provider compliance assessment focuses on outcomes for the 16 core quality and safety standards in part 4 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2009. These include: Compliance es / o Outstanding Trust Issues to Enhance Compliance 1. Involvement and Information 2. Personalised care, treatment and support 3. Safeguarding and Safety 4. Suitability of Staffing 5. Quality and Management 6. Suitability of Management Outcome Regulation Description 1 17 Respecting and involving people who use services es 2 18 Consent to care and treatment es 3 19 Fees es 4 9 Care and welfare of people who use services - 5 14 Meeting nutritional needs es 6 24 Cooperating with other providers es 7 11 Safeguarding vulnerable people who use services Adults es Safeguarding vulnerable people who use services Children es 8 12 Cleanliness and infection control Assurance through es Infection Control board reports 9 13 Management of medicines es 10 15 Safety and suitability of premises o 11 16 Safety, availability and suitability of equipment - 12 21 Requirements relating to workers es 13 22 Staffing es 14 23 Supporting workers es 15 This outcome relates to Statement of Purpose and does not require a compliance statement 16 10 Assessing and monitoring the quality of service provision es 17 19 Complaints es 18 This outcome relates to notifying CQC of a death 19 This outcome relates to notifying CQC of absconsion of a patient detained under the Mental Health Act. 20 This outcome relates to the notification of other incidents 21 20 Records es 21 20 Other Records es 22 This outcome concerns registering as a service 23 This outcome concerns registering as a body or partnership. 24 This outcome concerns the duty of registered managers if a condition is imposed on a service 25 This outcome is about the registered person 26 This outcome relates to the financial position and is subject to scrutiny through corporate governance arrangements. 27 This is about notification of the absence of the nominated individual. 28 This is about the notification of the departure of the nominated individual. 2

Summary of the outstanding Trust issues to enhance compliance and address gaps in Management of Medicines and Complaints SECTIO 3 Safeguarding and Safety Outcome 9 / Regulation 13 Management of Medicines People who use services: Will have their medicines at the times they need them, and in a safe way. Wherever possible will have information about the medicine being prescribed made available to them or others acting on their behalf. Recruitment of further Pharmacy staff Target Date 30/9/10 Keble Responsible Development of Pharmaceutical Care Plans for Patients 30/9/10 Lindsay Extension of Intervention Recording-related to staffing 30/9/10 Lindsay 30/9/10 and Self medication policy development and audit Lindsay 31/12/10 Update of policy for Safe Handling of Clinical Trial Medicines 31/8/10 Lindsay Audits being planned- need Medicines Safety Pharmacist 30/9/10 Keble Repeat Storage audit Responses ongoing- need Medicines Safety Pharmacist 31/3/11 Develop nurse and doctor training 31/3/11 Develop staff competency assessments 31/3/11 Develop policy for provision of medicines information 30/9/10 31/3/11 Keble Register / SECTIO 5 Quality and Management Outcome 17 / Regulation 19 Complaints Patients/People who use the service can be sure that their comments and complaints are listed to and acted on effectively Know that they will not be discriminated against for making a compliant Target Responsible Register Date / Introduction of Patient Satisfaction Survey in order to monitor the complainants view of how their complaint has been handled Clarify processes for divisional review of action plans and monitoring of implementation of recommendations. Review of Complaints Litigation, Incident and PALS group and report to enhance impact of complaints on improving practice. End of June 2010 1 October 2010 Mark Jarvis, Susan Black Mark Jarvis Questionnaire agreed and being issued July 2010 CLIP review of terms of reference and membership underway. 3

Outcome 10 - Registration Compliance Report Appendix 1 SECTIO 3 Safeguarding and Safety Outcome 10 / Regulation 15 Safety and Suitability of Premises People /Pts who use services are in safe, accessible surroundings that promote their wellbeing Prompts 10A K Summary of Compliance: People receiving care, treatment and support have their individual needs met because the premises: - are fit for purpose - are fully accessible in keeping with the requirements of the Disability Discrimination Act (DDA) 1995 - have a design and layout that takes account of relevant design, technical and operational standards. - meet health and safety at work act 1974 and regulatory reform (fire safety) order 2005 and other relevant legislation - protects peoples privacy, dignity, safety, has heating, space, lighting and ventilation that conforms to relevant and recognised standards - have safe and secure storage facilities, have sufficient toilets, bathrooms and bathing facilities, access to facilities for infant feeding, have call alarm systems, somewhere private for breaking bad news. Medical gas cylinders and pipe lines are properly installed and maintained and pt safety communications relating to these are followed up Arrangements and licences are in place for safe collection, classification, segregation, storage, handling, transport, treatment and disposal of clinical waste in line with regulations Arrangements are in place to meet COSSH regulations 2002 There are clear procedures which are practiced, monitored and reviewed which cover how the premises are maintained, identification and management of risks, waste management. Plans are developed and implemented for the adaption of premises in response to changes in pts needs, issued guidance and legislation. The management of risk includes the prevention and control of legionella There are systems in place to ensure that the décor of the building is maintained and refreshed Security arrangements are regularly monitored and reviewed so that the premises are safe and secure for people using the services, staff and others Staff work effectively to meet people s needs because suitable facilities are provided. For example, there are sufficient staff toilets, changing rooms, rest facilities, access to a telephone. Executive : People who use the services are safe because we provide facilities in line with legislation for the safe handling of radionucleides required for scanning and treatment. Joint Responsibility Sarah Wiles Director of Kyle Mcclelland Interim Associate Director Hotel Outcome Co-ordinator: Strategy & Infrastructure Services Eric Fehily Interim Associate Director of Estates Responsible Committee(s): Delivery Service Group Executive Team 1.Other contributors: Please detail the names and job titles of those who contribute to providing evidence / assurance of compliance. 2.Compliance Status: (see Judgement Framework) Compliant Minor Concern Moderate Concern Major Concern If a negative outcome has been identified what is the impact on service users? Low, Medium or High What is the likelihood of the negative outcome occuring? Unlikely, Possible, Almost Certain Potentially Almost certain 3.Rationale for compliance status: Please state the rationale for the compliance status declared above. Recorded incidents on security are no worse than other similar Trusts, but compliance cannot be claimed owing to substantial failings in security CCTV coverage and instructions to contracted staff. Backlog maintenance 66.36 million egative survey and Compliance reports since 2008 indicated gaps in resilience/compliance HSE reports following inspections 4.Available evidence: Please detail the evidence available to support the compliance status. Wherever possible this must be held electronically, it must be kept upto-date and made available upon request. 6 Facet Survey ERIC return data 4

Backlog Maintenance Schedule Estates Strategy Compliance and resilience reports HSE/Fire service reports DoH ERICreturn data 5.Gaps in assurance: Please detail any gaps in providing assurance of compliance. Operational Documentation shows some non compliance Review of policies and procedures requires significant time and investment to resolve Staff training to meet HTM/HB standards 6. Location (Site or Specific area) affected by Gap? WGH, SACH, HHGH 7. Actions required to achieve: Please detail the actions being taken to ensure compliance is achieved or maintained, this must include the target date for achievement and the individual responsible for ensuring actions are taken forward and achieved. Target Date Investment in security system (CCTV) Dec 2010 Strengthen Instructions and service for security Dec 2010 Responsible Kyle McClelland Kyle McClelland Approval has been given to implement new system Requirements currently being scoped. Full time LSMS recently appointed and progressing the wider security issues Register / Investment in the Estate (27M indicated in Estates Strategy) 2010 2014 Sarah Wiles ew estates structure focussing on compliance/resilience 2010 Sept. Eric Fehily 75% complete Possible new hospital which will remove the concerns which currently exist TBC Sara Wiles Policies and Procedures require updating with significant 12 24 investment months Eric Fehily 20% complete Estates annual plan for 2011/12 to be prepared Dec. 2010 Eric Fehily 0% early KPI s to be prepared to the Trust Board Sept. 2010 Eric Fehily 0% Training compliance report to be prepared Sept. 2010 Eric Fehily 75% complete 8. Impact of Improvements & Monitoring: Based on the actions detail above state the impact the improvements will have on patients/people who use the service and how these will be monitored. Reduce damage to estate / providing a better environment reduce likelihood of an attack Provide evidence in event of criminal activity / AWOL patients / Routine security reports (SIRS) If all the above estates actions are progressed will be able to declare compliance Improved patient experience Improved service to staff Reduced clinical service interruptions KPI s both nationally and locally agreed and monitored o ALL COMPLIACE REPORTS MUST BE SIGED B BOTH THE OUTCOME AD EXECUTIVE LEAD. Outcome Co-ordinator Executive Kyle McClelland Eric Fehily Sarah Wiles Date: 7 th September 2010 Date: 7 th September 2010 5

SECTIO 3 Safety and Safeguarding Outcome 11 - Registration Compliance Report APPEDIX 2 Outcome 11 / Regulation 16 Executive : Safety, availability and suitability of equipment People using the service and people who work in or visit the premises: - Are not at risk of harm from unsafe or unsuitable equipment (medical and nonmedical equipment, furnishings or fittings). - Benefit from equipment that is comfortable and meets their needs. Sarah Wiles Director of Strategy & Infrastructure Outcome Co-ordinator: Eric Fehily Interim Director of Estates Responsible Committee(s): Medical Devices Committee Brain Lane Clinical Engineering 1.Other contributors: Bruce Kerr Resuscitation Officer eed lead for single use devices? Please detail the names and job titles of those who contribute to providing evidence / assurance of compliance. 2.Compliance Status: (see Judgement Framework) Compliant Minor Concern Moderate Concern Major Concern If a negative outcome has been identified what is the impact on service users? Low, Medium or High What is the likelihood of the negative outcome occuring? Unlikely, Possible, Almost Certain Medium Possible 3.Rationale for compliance status: Maintenance schedules are not always carried out in accordance with manufactures recommendations for maintenance, example 6 months 12 months or 24 months, although there is currently a backlog. Currently training is provided through supplier for new equipment, clinical engineering is in the process of recruitment for a device training lead, this action links to the training policy currently being drafted, deadline for device training policy is 26 May 2010. There is limited medical device training for new staff or ongoing competency training provided by clinical engineering. There is some medical device training provided through Training and Development. Records of previous medical device training via clinical engineering are unavailable due to retirement of medical device training lead. All safety alerts (related to Clinical engineering) are actioned appropriately and in accordance with published guidelines and recommendations. AAU medical device training records held but not held centrally assurance would need to be provided by the appropriate divisions The department does follow all MHRA guidance on medical devices. Existing database of equipment needs a refresh due to the recent changes in clinical services and equipment which has been purchased directly with CE knowledge Medical devices Policy needs to be refreshed 4.Available evidence: Please detail the evidence available to support the compliance status. Wherever possible this must be held electronically, it must be kept upto-date and made available upon request. Evidence of records in both electronic and hard copies are available Medical Devices Policy Bi Monthly performance reports 5.Gaps in assurance: Please detail any gaps in providing assurance of compliance. The medical devices trainer retired which effects medical device training, currently in the process of recruitment that will link to training policy being drafted There is a shortage of fetal monitoring machines Maternity are putting together a business case to purchase 14 new machines Database of equipment needs updating Backlog on planned maintenance of equipment. 6

6. Location (Site or Specific area) affected by Gap? SECTIO 3 Safety and Safeguarding 7. Actions required to achieve: Please detail the actions being taken to ensure compliance is achieved or maintained, this must include the target date for achievement and the individual responsible for ensuring actions are taken forward and achieved. Target Date Responsible Business Case for Fetal Monitoring Machines TBC TBC Review of Dept. Equipment s for equipment Eric Fehily/ Oct/ovember 2010 management and equipment training atalie Forrest Work started Clinical Engineering representative to attend medical devices since September 2010 Brian Lane committee and equipment sub committee June 2010 Development of Training Policy May 2010 Eric Fehily Starts on 27 th September Appointment of medical device trainer 27 th September Eric Fehily Starts on 27 th September Refresh Equipment database and update register to reflect true amount of equipment in service / use 30 th September Brian Lane Almost complete 8. Impact of Improvements & Monitoring: Trust Board will have assurance that staff will have been trained to use medical device equipment and manage equipment in each department. Patients will have the benefit of having trained staff using medical equipment to enhance their recovery. Register / Improved Clinical engineering process on the management of equipment, more accurate database will save time and money chasing missing equipment. 9. ALL COMPLIACE REPORTS MUST BE SIGED B BOTH THE OUTCOME AD EXECUTIVE LEAD. Outcome Co-ordinator Executive Eric Fehily Sarah Wiles Date: September 2010 September 2010 Colin Johnston Medical Director September 2010 7