Quality Standards for Enhanced Primary Care Services. Version 1.2

Quality Standards for Enhanced Primary Care Services Version 1.2 September 2014 8831

September 2014 West Midlands Quality Review Service These Quality Standards may be reproduced and used freely by NHS and social care organisations in the West Midlands for the purpose of improving health services for residents of the West Midlands and those who use West Midlands services. No part of the Quality Standards may be reproduced by other organisations or individuals or for other purposes without the permission of the West Midlands Quality Review Service. Organisations and individuals wishing to reproduce any part of the Quality Standards should email the West Midlands Quality Review Service on: swb-tr.swbh-gm-wmqrs@nhs.net. Whilst the West Midlands Quality Review Service has taken reasonable steps to ensure that these Quality Standards are fit for the purpose of reviewing the quality of services in the West Midlands, this is not warranted and the West Midlands Quality Review Service will not have any liability to the service provider, service commissioner or any other person in the event that the Quality Standards are not fit for this purpose. The provision of services in accordance with these Standards does not guarantee that the service provider will comply with its legal obligations to any third party, including the proper discharge of any duty of care, in providing these services. Review by: July 2018 Version No. Date Change from previous version V1.1 22.07.2015 Review date updated to July 2018 V1.2 09.02.2016 Paragraph added about organisation s clinical governance arrangements UKAS accreditation logo added WMQRS Primary Care Services QSs V1.2 20160209 2

CONTENTS INTRODUCTION... 4 QUALITY STANDARDS... 6 Practice-Based Service... 6 Information and Support for Patients and Carers... 6 Staffing... 8 Support Services... 9 Facilities and Equipment... 10 Guidelines and Protocols... 11 Service Organisation and Liaison with Other Services... 11 Governance... 12 Commissioning... 13 Appendix 1 Reference Sources... 15 Appendix 2 Cross-References to Care Quality Commission and NHS Litigation Authority Standards... 17 Appendix 3 Glossary of Terms and Abbreviations... 20 Appendix 4 Presentation of Evidence for Peer Review s... 21 WMQRS Primary Care Services QSs V1.2 20160209 3

INTRODUCTION These Quality Standards for Enhanced Primary Care Services were developed through joint work between Solihull Clinical Commissioning Group (CCG), interested general practitioners from Solihull and the West Midlands Quality Review Service (WMQRS). Through the use of these Quality Standards locally and for peer review visits: a. Patients and carers will know more about the services they can expect. b. Commissioners will be supported in assessing and meeting the needs of their population, improving health and reducing health inequalities, and will have better service specifications. c. Service providers and commissioners will work together to improve service quality. d. Service providers and commissioners will have external assurance of the quality of local services. e. Reviewers will learn from taking part in review visits. f. Good practice will be shared. g. Service providers and commissioners will have better information to give to the Care Quality Commission. SCOPE OF QUALITY STANDARDS These Quality Standards apply to enhanced services in primary care. They are therefore over and above the services expected under providers general medical services (GMS) or personal medical services (PMS) contracts. The Quality Standards assume that GMS or PMS of appropriate quality, as judged by the Care Quality Commission, are in place. Where the term the service is used, this refers to the enhanced service (and not to the GMS or PMS provided by the practice). These Quality Standards were developed specifically for anticoagulation services (monitoring only or initiation and monitoring), near patient testing and monitoring of a range of drugs, and monitoring of stable prostate cancer in primary care. The Standards could however be applied to other enhanced services in primary care. The Standards apply to the care of adults and will not include all the requirements for services for children and young people. The Quality Standards for Enhanced Primary Care Services should sit within organisations overall clinical governance arrangements. The WMQRS Clinical Governance Quality Standards describe the clinical governance arrangements which should be in place. Compliance in NHS provider organisations will usually be assured through NHS Litigation Authority Standards. Non-NHS organisations may wish to use the WMQRS Clinical Governance Quality Standards to assure themselves of the robustness of their overall clinical governance arrangements. WMQRS Primary Care Services QSs V1.2 20160209 4

STRUCTURE OF THE QUALITY STANDARDS Each Standard is structured as follows: Reference Number (Ref) This column contains the reference number for each Standard, which is unique to these standards and is used for all cross-referencing. Each reference number is composed of two letters and three digits (see below for more detail). The reference column also includes a guide to how the Standard will be reviewed: Background information ing facilities Meeting patients, carers and staff Case note review or clinical observation umentation The shaded area indicates the approach that will be used to reviewing the Quality Standard. Appendix 4 summarises the evidence needed for review visits. Quality Standard (QS) Notes This describes the quality that services are expected to meet. The notes give more detail about either the interpretation or the applicability of the Standard. Pathway and Service Letters: The Standards are in the following sections: NM- Enhanced Primary Care Services Practice-Based Service NZ- Enhanced Primary Care Services Commissioning Topic Sections: Each section covers the following topics: -100 Information and Support for Patients and Carers -200 Staffing -300 Support Services -400 Facilities and Equipment -500 Guidelines and Protocols -600 Service Organisation and Liaison with Other Services -700 Governance Service-Specific Suffixes Most of the Quality Standards apply to the three enhanced primary care services covered by this document. A few Standards apply only to anticoagulation services. These have a suffix to the reference number to show this: A Anticoagulation Service COMMENTS ON THE QUALITY STANDARDS The Quality Standards will be revised as new national guidance becomes available and as a result of experience of their use in peer review. Comments on the Quality Standards are welcomed and will be taken into account when they are updated. Comments should be sent to swb-tr.swbh-gm-wmqrs@nhs.net. More information about WMQRS and its Quality Standards and reviews is available at www.wmqrs.nhs.uk or by calling 0121 507 2891. WMQRS Primary Care Services QSs V1.2 20160209 5

QUALITY STANDARDS PRACTICE-BASED ENHANCED PRIMARY CARE SERVICE Ref Standard INFORMATION AND SUPPORT FOR PATIENTS AND CARERS NM-101 NM-102 Service Information Each practice should offer patients and their carers written information covering: a. Organisation of the practice-based service, such as opening hours and clinic times b. Arrangements for patients who are housebound c. Staff available d. How to contact the service for help and advice e. How to complain about the service, including details of where complaints should be directed Notes: 1 Information should be written in clear, plain English and should be available in formats and languages appropriate to the needs of the patients. 2 Information may be in paper or electronic/e-learning formats. Guidance on how to access information is sufficient for compliance so long as this points to easily available information of appropriate quality. If the information is provided only in individual patient letters then examples will need to be seen by reviewers. 3 Information may be combined with condition-specific information (QS NM-102). 4 Complaints about the service should be directed to the CCG. Condition-Specific Information Patients and their carers should be offered up to date, written information about their condition and its impact. A note of the information given should be made available in the patient s medical record. Notes: 1 As QS NM-101 notes 1 and 2. 2 Information may be in the form of national or locally produced booklets and combined with service information (QS NM-101). 3 Relevant patient information may be available via Map of Medicine pathways. 4 Condition-specific information should cover: a. Brief description of the condition and its impact b. Possible complications and how to prevent these c. Pharmacological and non-pharmacological therapeutic interventions offered by the service d. Possible side-effects of therapeutic interventions e. Symptoms and action to take if unwell, including out of hours help and advice f. Sources of further advice and information Anticoagulation only. g. Dietary and alcohol restrictions h. For frail older patients and their carers: depression, skin integrity, falls and mobility, continence, safeguarding issues, delirium and dementia, nutrition and hydration, sensory loss and activities of daily living. WMQRS Primary Care Services QSs V1.2 20160209 6

Ref NM-103 Management Plan Standard NM-104 NM-196 NM-199 Each patient and, where appropriate, their carer should discuss and agree their Management Plan, and should be offered a written record covering at least: a. Agreed goals, including life-style goals b. Self-management c. Importance of complying with the monitoring regime d. Planned therapeutic interventions e. Early warning signs of problems, and what to do if these occur f. Planned review date and how to access a review more quickly, if necessary g. Who to contact with queries or for advice Review of Management Plan A formal review of the patient s Management Plan should take place at least annually: a. Anticoagulation service: INR checked at least every eight weeks and more often if indicated by test results b. Prostate cancer monitoring: As indicated in the monitoring plan provided by the responsible consultant c. Near patient testing: As specified in clinical guidelines (QS NM-501) This review should involve the patient, where appropriate, their carer, and appropriate members of the multi-disciplinary team (if required). Notes: 1 Anticoagulation: A minimum frequency of eight weeks is included in the QS so that the national standard of 12 weeks can still be achieved for example, if a patient does not attend and follow-up is required. 2 Prostate cancer monitoring: In exceptional circumstances, if the patient and GP agree that the monitoring plan provided by the consultant is not appropriate, this should be documented in the patient s notes. Discussion with the consultant is also encouraged. Discharge Information Patients for whom the primary care service is no longer appropriate should discuss and agree: a. Arrangements for their future care b. Ongoing self-management of their condition c. Possible complications and what to do if these occur This discussion should be documented in the patient s notes. Note: Indications for discharge from the service are covered in the relevant clinical guidelines (QS NM- 501). Discussion may be supplemented by written information. Involving Patients and Carers The service should have: a. Mechanisms for receiving regular feedback from patients and carers about the treatment and care they receive from the service b. Examples of changes made as a result of feedback and involvement of patients and carers Note: NICE Commissioning Guidance, CMG 49, Support for Commissioning (2013), suggests patient satisfaction surveys should cover accessibility of venues or domiciliary visits, availability of convenient appointment times especially for working age adults, and choice of anticoagulation therapy. WMQRS Primary Care Services QSs V1.2 20160209 7

Ref Standard STAFFING NM-201 NM-202 NM-203 Lead Clinician A nominated lead clinician should have responsibility for the effective delivery of the service, including staffing, training, guidelines and protocols, service organisation, governance and liaison with other services. The lead clinician should be a registered healthcare professional with appropriate specialist competences in this role and should undertake regular clinical work within the service. Note: It is recommended that the lead clinician has specific time allocated for this role. Staffing Levels and Skill Mix Sufficient staff with appropriate competences should be available for: a. The number of patients usually cared for by the service and the usual case mix of patients b. The service s role in the patient pathway and expected timescales c. The assessments and therapeutic interventions offered by the service d. Urgent review if clinically indicated Cover for absences should be available so that the patient pathway is not unreasonably delayed, and patient outcomes and experience are not adversely affected, when individual members of staff are away. Service Competences and Training Plan The competences expected for each role in the service should be identified, including: a. Clinical competences for the service provided b. Development and maintenance of a practice register of patients c. Running the call and recall system d. Adverse events reporting A training and development plan for achieving and maintaining competences should be in place. Notes: 1 This QS is about the needs of the service and cannot be met solely by individual staff appraisals and personal development reviews (PDRs). Appraisals and PDRs are sufficient for maintenance of competence, and details of individual appraisals and PDRs are not required. Reviewers may, however, request information about specific aspects of relevance to the service, particularly where a therapeutic intervention or activity is undertaken rarely and/or where competence may not be maintained by the individual s usual clinical practice. 2 For compliance with this QS the service should provide: a. A matrix of the roles within the service, competences expected and approach to maintaining competences b. A training and development plan showing how competences are being achieved and maintained. 3 Training may be delivered through a variety of mechanisms, including e-learning. 4 Commissioners may specify a requirement for specialist competences and, if so, these (or equivalent) should be achieved by providers. WMQRS Primary Care Services QSs V1.2 20160209 8

Ref NM-203A NM-299 Standard Service Competences and Training Plan Anticoagulation Service Staff providing an anticoagulation service should have competences appropriate to their role in: a. Anticoagulation monitoring b. Use of appropriate anticoagulation Near Patient Testing equipment c. Use of Computer Software Decision Support (CSDS) to assist in dose calculation and running audits (QS NM-499A) d. Dose decisions: A registered healthcare professional who, if not medically qualified, has completed an accredited course in anticoagulation management Notes: 1 This QS is additional to QS NM-203. 2 Courses run by the University of Birmingham and the University of Hertfordshire are examples of accredited courses. 3 Further information on appropriate competences is available on the Skills for Health website (Currently under development; link will be added when available). Administrative, Clerical and Data Collection Support Administrative, clerical and data collection support should be available. Note: The amount of administrative, clerical and data collection support is not defined. Clinical staff should not, however, be spending unreasonable amounts of time that could be used for clinical work on administrative tasks. SUPPORT SERVICES NM-301 Services providing Support and Advice to Practices Timely access to an appropriate range of support services should be available, including: a. Consultant-led haematology service (anticoagulation service only) b. Consultant-led stroke service (anticoagulation service only) c. Consultant-led urological cancer service (prostate cancer monitoring only) d. Consultant-led service for each drug or condition (near patient testing only) e. Consultant specialising in the care of frail older people Notes: 1 Timely is not defined strictly but should ensure that patient pathways are not unreasonably delayed and that the service s timescales for assessments and therapeutic interventions are not unreasonably delayed. Specific indications for referral to, and timescales for response by, support services may be agreed. Support services include imaging, pathology, pharmacy and other services relevant to the particular patient pathway. Ancillary services such as porters, security and cleaning should be included where they are specifically relevant to the service provided or the case mix of patients. 2 For compliance with this QS, services should provide a list of essential support services, indications for urgent and routine referral and agreed response times (urgent and routine). An audit of compliance with referral indications and response times is desirable. WMQRS Primary Care Services QSs V1.2 20160209 9

Ref Standard FACILITIES AND EQUIPMENT NM-401 NM-402A NM-499 NM-499A Facilities Facilities available should be appropriate for the assessment and therapeutic interventions offered by the service for the usual number and case mix of patients, including appropriate arrangements for: a. Infection prevention b. Management of sharps c. Storage, including refrigerated storage when required Note: Required facilities and equipment are not strictly defined but should be appropriate for the usual number and case mix of patients cared for by the service. Equipment Anticoagulation Service Timely access to appropriate equipment should be available including: a. Roche Near Patient Testing equipment plus an additional monitor for any branch surgery b. Appropriate Roche Diagnostics consumables c. Quality assurance of equipment by an external provider (four surveys of two samples per machine per annum) Notes: 1 As QS NM-401. 2 Timely is not defined strictly but availability of equipment, including consumables, should not unreasonably delay patient pathways or adversely affect patient outcomes and experience. 3 An appropriate external provider is the UK National External Quality Assurance Scheme (NEQAS). IT System IT systems for storage, retrieval and transmission of patient information should be in use for patient administration, clinical records, outcome information and other data to support service improvement, audit and revalidation. Note: IT and records systems should be integrated to avoid duplicate entry of patient data. IT System Anticoagulation Practices should use the Computer Software Decision System (CSDS) made available by commissioners (QS NZ-499A) for developing and maintaining an up to date register of patients, call and recall of patients, indication and duration of treatment, target INR and dose calculations, and audits. Notes: 1 This QS is additional to QS NM-499. 2 The CSDS provides guidance only. Responsibility for dose decisions rests with the responsible clinician. WMQRS Primary Care Services QSs V1.2 20160209 10

Ref Standard GUIDELINES AND PROTOCOLS NM-501 Clinical Guidelines Up to date locally agreed clinical guidelines should be in use covering: a. Diagnosis and assessment b. Interventions offered by the service c. Monitoring and follow-up d. Anticoagulation service only: Action to take if INR, with or without symptoms, is: i. Between 5.0 and 7.9 ii. 8.0 or above e. Indications for contacting the relevant consultant-led service (QS NM-301) f. Discharge from the service Note: Local Map of Medicine pathways (QS NZ-501) provide access to local pathways, locally agreed guidelines and NICE guidance. SERVICE ORGANISATION AND LIAISON WITH OTHER SERVICES NM-601 NM-602 Operational Policy The service should have an operational policy describing the organisation of the service including at least: a. Responsibility for giving patient and / or carer information at each stage of the patient journey b. Arrangements for care of people who are housebound or resident in a care home c. Arrangements for care of working age adults who are not easily able to access the practice during the core contract hours of 8:00am to 6:30pm, Monday to Friday d. Arrangements for follow-up of patients who do not attend e. Arrangements for multi-disciplinary discussion of appropriate patients f. Arrangements for liaison with key services providing support and advice (QS NM-301) g. Arrangements for maintenance of equipment (QS NM-402A) h. Responsibilities for IT systems (QS NM-499) i. Call and recall system arrangements and responsibilities for these j. Recording and reporting incidents to the CCG k. Anticoagulation service only: i. Quality assurance of equipment by an external provider (four surveys of two samples per machine) ii. Arrangements for ordering testing strips iii. Arrangements for reporting as an adverse incident to the CCG within 72 hours all patients with an INR of 8.0 or above Notes: 1 Failure to report patients with an INR of 8.0 or above to the CCG within 72 hours will comprise constitute a breach of contract 2 An incident is an unexpected event that had an actual, or potential, adverse impact on the patient s health or well-being and that a) requires investigation and / or b) could provide learning in order to avoid a recurrence within the practice or elsewhere. Participation in Local Review and Learning Meetings A representative of the service should attend each Local Review and Learning Meeting (QS NZ-602). Note: Review and Learning Meetings may be service-specific or may cover more than one service. Wherever possible, the lead clinician (QS NM-201) should attend these meetings. WMQRS Primary Care Services QSs V1.2 20160209 11

Ref Standard GOVERNANCE NM-701 Data Collection Regular collection and monitoring of data should be in place, including: a. Referrals to the service, including source and appropriateness of referrals b. Number of patients seen by the service c. Number of annual reviews undertaken d. Number of patients who do not attend and number who do not attend for more than four weeks e. Number of discharges from the service and type of care after discharge f. Number of incidents reported to the CCG g. Key performance indicators h. Uploading of external quality assurance results to Computer Software Decision Support (CSDS) (anticoagulation service only) Notes: 1 Data collection for anticoagulation services will be through the CSDS. For other services, templates for key performance indicators and for audit may also be available through clinical systems. 2 Key Performance Indicators for anticoagulation services are: Proportion of patient-time in range or percentage of INRs Percentage of INRs > 5.0 Percentage of INRs > 8.0 Percentage of INRs > 1.0 INR unit below target Percentage of patients suffering adverse outcomes, categorised by type Percentage of patients lost to follow-up (and risk assessment of process management for identifying patients lost to follow-up) NM-702 NM-703 Audit The service should have a rolling programme of audit of compliance with: a. Evidence-based clinical guidelines (QS NM-501) b. Annual audit of proportion of patients who have had an annual review c. Anticoagulation services: Ongoing audit of Key Performance Indicators (QS NM-701) made available to commissioners on request. d. Near patient testing services: i. Patients have documented drug monitoring within the recommended time frames ii. Appropriate parameters are monitored for each drug iii. Blood monitoring results are within the recommended range iv. Patients have a documented indication for high-risk drugs Audit Information for Commissioners The service should comply with commissioner requests for: a. Announced and unannounced visits b. Reasonable additional audit information NM-798 Multi-disciplinary Review and Learning The service should have multi-disciplinary arrangements for: a. Review of and implementation of learning from positive feedback, complaints, outcomes, incidents and near misses b. Ongoing review and improvement of service quality, safety and efficiency WMQRS Primary Care Services QSs V1.2 20160209 12

Ref NM-799 ument Control Standard All policies, procedures and guidelines should comply with reasonable document control standards. Note: ument control standards include date agreed, author, version numbers and review date. COMMISSIONING Ref NZ-499A NZ-501 Standard Computer Software Decision Support for Anticoagulation Services The commissioner should: a. Commission for use in practices a Computer Software Decision Support (CSDS) for developing and maintaining an up to date register of patients, call and recall of patients, indication and duration of treatment, target INR and dose calculations, and audits b. Commission quality assurance of equipment by an external provider (four surveys of two samples per machine per annum) Note: CSDS commissioning should include required patient licences. Clinical Guidelines The commissioner should make available up to date clinical guidelines that have been agreed with relevant local consultant-led services. Note: The use of these guidelines in practices is covered in QS NM-501. NZ-601 NZ-602 NZ-703 Commissioning of Services Services for each patient pathway should be commissioned: a. Anticoagulation monitoring (Level 4 service) b. Anticoagulation initiation and monitoring (Level 5 service) c. Near patient testing d. Management of stable prostate cancer Criteria for referral to and discharge from each service should be specified. Key performance indicators and specific incidents that should be notified to commissioners may also be defined. Local Review and Learning Meetings The commissioner should arrange a local review and learning meeting at least annually for each type of service. These meetings may include updating clinical guidelines, staff training and review of audit results. Notes: 1 Attendance at these meetings by representatives of each practice is covered by QS NM-602. 2 Review and Learning Meetings may be service-specific or may cover more than one service. Quality Monitoring The commissioner should monitor key performance indicators, audit results (QS NM-702) and aggregate data on activity and outcomes from each service at least annually. WMQRS Primary Care Services QSs V1.2 20160209 13

Ref NZ-703A Quality Monitoring Anticoagulation Services Standard The commissioner should run relevant Computer Software Decision Support audits at least six monthly and ensure that these are reviewed by the Clinical Lead for the service. WMQRS Primary Care Services QSs V1.2 20160209 14

APPENDIX 1 REFERENCE SOURCES Year Publisher Title Reference number 2014 National Institute for Health and Care Excellence (NICE) Prostate Cancer Diagnosis and Treatment. NICE Clinical Guideline 175 18 2013 National Institute for Health and Care Excellence (NICE) Support for Commissioning: Anticoagulation Therapy 6 2013 Social Care Institute for Excellence 2013 Social Care Institute for Excellence 2013 Social Care Institute for Excellence 2013 Royal College of General Practitioners Evidence Review on Partnership Working between GPs, Care Home Residents and Care Homes Adult Services Guide 52, GP Services for Older People: A Guide for Care Home Managers Improving Access to and Experience of GP Services for Older People Living in Care Homes: Practice Survey RCGP Submission to the Joint Committee on the Draft Care & Support Bill 7 8 9 13 2013 National Institute for Health and Care Excellence (NICE) 2013 National Institute for Health and Care Excellence (NICE) Clinical Knowledge Summary: DMARDS Penicillamine, Sulphasalazine, Methotrexate, Leflunomide, Ciclosporin, Azathioprine. http://cks.nice.org.uk/dmards CMG 49 - Support for Commissioning- anticoagulation 21 14 2013 NHS Litigation Authority NHSLA Risk Management Standards 2013-14 for NHS Trusts providing Acute, Community, or Mental Health & Learning Disability Services and Non-NHS Providers of NHS Care 2012 National Clinical Guideline Centre Venous Thromboembolic Diseases: The Management of Venous Thromboembolic Diseases and the Role of Thrombophilia Testing 2012 Anticoagulation Europe (UK) Commissioning Effective Anticoagulation Services for the Future 20 3 4 2012 National Institute for Health and Care Excellence (NICE) Good Practice Guidance: Developing and Updating Local Formularies 19 2011 British Geriatrics Society Joint Working Party Inquiry into the Quality of Healthcare Support for Older People in Care Homes: A Call for Leadership, Partnership and Quality Improvement 2010 Suffolk Primary Care Trust NHS Suffolk Drug and Therapeutics Committee Guidance on Monitoring of Drugs in Primary Care 15 16 2009 NHS Stroke Improvement Programme 2008 Trends in Urology, Gynaecology & Sexual Health NHS Evidence: Atrial Fibrillation Detection and Optimal Therapy in Primary Care The role of the GP in prostate cancer care (Richard D Neal) Vol 13, 5 1 17 2006 National Institute for Health and Care Excellence (NICE) Information for the Public: Atrial Fibrillation 11 WMQRS Primary Care Services QSs V1.2 20160209 15

Year Publisher Title Reference number 2006 National Institute for Health and Care Excellence (NICE) The Management of Atrial Fibrillation 2 2006 National Coordinating Centre for the Service Delivery and Organisation (NCCSDO) - Royal College of General Practitioners Outpatient Services and Primary Care: A Scoping Review of Research into Strategies for Improving Outpatient Effectiveness and Efficiency Care Homes Case Study Sheffield Locally Enhanced Service (LES) 5 12 The table below shows the links between the Quality Standards and key guidance documents. Quality Standards without a reference source are based on the consensus view of the Groups that developed the Standards, taking into account comments received. QS reference Guidance documents QS reference Guidance documents QS reference Guidance documents NM-101 2, 8, 9, 11, 17, 18 NM-401 1 NZ-499A 4, 6, 15 NM-102 2, 6, 8, 11, 15, 17, 18 NM-402A 6 NZ-501 1, 4, 6 NM-103 8, 9, 11, 13, 15, 18 NM-499 NZ-601 4, 6, 18 NM-104 8, 17, 18 NM-499A 6 NZ-602 4, 6, 9, 12, 15 NM-196 11, 13, 18 NM-501 1, 3, 6, 13, 16, 18 NZ-703 6, 15 NM-199 4, 6, 15, 18, 19, 21 NM-601 6, 12, 13 NZ-703A 1, 6 NM-201 7, 8, 15, 17, 18, 19 NM-602 4, 12, 15 NM-202 1, 6, 7, 15, 19 NM-701 4, 6, 8, 17, 18 NM-203 6, 7, 14, 15, 19 NM-702 1, 2, 4, 6 NM-203A 4, 6 NM-703 1, 2, 6, 15 NM-299 NM-798 4, 5, 12 NM-301 14, 15, 16, 18 NM-799 20 WMQRS Primary Care Services QSs V1.2 20160209 16

APPENDIX 2 CROSS-REFERENCES TO CARE QUALITY COMMISSION AND NHS LITIGATION AUTHORITY STANDARDS Shaded boxes show where a WMQRS Quality Standard addresses one of the Care Quality Commission s Draft Fundamental Standards, Key Questions and Regulation 20: Duty of Candour (applicable for NHS bodies from October 2014 and for all other care providers from April 2015). This table will be updated when the final version of the CQC Standards is available later in 2015. The table also shows links between WMQRS Quality Standards and NHSLA Risk Management Standards. Ref CQC Five Key Questions 1 Is it safe? 2 Is it effective? 3 Is it responsive? 4 Is it caring? 5 Is it well-led? Ref a b c d e f g h i j k CQC Draft Fundamental Standards Care and treatment must reflect service users needs and preferences Service users must be treated with dignity and respect Care and treatment must only be provided with consent All care and treatment provided must be appropriate and safe Service users must not be subject to abuse Service users nutritional needs must be met All premises and equipment used must be safe, clean, secure, sustainable for the purpose for which they are being used, and properly used and maintained Complaints must be appropriately investigated and appropriate action taken in response Systems and processes must be established to ensure compliance with these Fundamental Standards Sufficient numbers of suitably qualified, skilled and experienced staff must be deployed to meet these standards Persons employed must be of good character, have the necessary qualifications, skill and experience, and be capable of performing the work for which they are employed More detail can be found in Annex A; Introducing Fundamental Standards: Consultation on proposals to change CQC registration regulations; www.gov.uk/dh. Ref CQC New Regulations (2014 Consultation -Guidance on the Fit and Proper Person Requirements for Directors and the Duty of Candour Consultation www.cqc.org.uk) Regulation 20 Duty of Candour WMQRS Primary Care Services QSs V1.2 20160209 17

CQC Draft Fundamental Standards CQC Regulation CQC Five Key Questions NHSLA Risk Management Standards 2013/2014 QS a b c d e f g h i j k 20 1 2 3 4 5 NM-101 x x x x x * * * 2.3,2.8,2.10,5.2, 6.2 NM-102 x x x x * * * 2.3,2.8,2.10,5.2 NM-103 x x x x * * * * 2.3,2.8,2.10,5.2 NM-104 x x x x * * * * 2.3,2.8,2.10,5.2 NM-196 x x x x * * * * 2.10,2.8,4.10 NM-199 x x x x x * * * 2.3,2.8,2.10 NM-201 x x x * * NM-202 x x x * * * * NM-203 x x x * * * * NM-203A x x x * * * * 1.9,2.8,3.2,3.1,3.4 3.7,3.8,3.9,4.3 1.9,2.8,3.2,3.1,3.4 3.7,3.8,3.9,4.3 1.9,2.8,3.2,3.1,3.4 3.7,3.8,3.9,4.3 1.9,2.8,3.2,3.1,3.4 3.7,3.8,3.9,4.3 NM-299 x x x * * * * 3.1,3.4,3.7,3.8 NM-301 x x x x x * * * * 2.8 NM-401 x x x * * 4.1 NM-402A x x x * * 4.1,4.7 NM-499 x x x * * 1.7,1.8 NM-499A x x x * * 1.7,1.8 NM-501 x x * * 2.8,4.10 NM-601 x x x * * 2.2,2.8,2.10,5.2 NM-602 x x x * * 2.1,2.2,2.3,2.6,2.7,2.8,2.1 0 NM-701 x x x x * * * * 2.1,2.2,2.6 NM-702 x x * * * * 2.1,2.2,2.6 NM-703 x x x * * * * 2.1,2.2,2.6 NM-798 x x x x * * * * 2.1,2.2,2.6 NM-799 x x * 1.2 NZ-499A x x x * * 1.7,1.8,2.1 NZ-501 x x * * 2.1,2.8 NZ-601 x x x x * * * * NZ-602 x x x * * * * 2.1,2.2,2.6,4.1 WMQRS Primary Care Services QSs V1.2 20160209 18

CQC Draft Fundamental Standards CQC Regulation CQC Five Key Questions NHSLA Risk Management Standards 2013/2014 QS a b c d e f g h i j k 20 1 2 3 4 5 NZ-703 x x x x * * * * 2.1,2.2,2.6,4.1 NZ-703A x x x x * * * * 2.1,2.2,2.6,4.1 WMQRS Primary Care Services QSs V1.2 20160209 19

APPENDIX 3 GLOSSARY OF TERMS AND ABBREVIATIONS Advocacy Carer Commissioner CQC GP HealthWatch Incident INR Monitor NICE Provider QS Service provider Service commissioner Trust WMQRS Advocacy means to speak up for someone. It is about making things change because people s voices are heard and listened to. It s about making sure that people can make their own choices in life and have the chance to be as independent as they want to be. Background information. Throughout the Quality Standards the term carer applies to both family carers and paid carers or support workers. A commissioner decides how NHS and / or social care resources are spent, with the aim of improving health, reducing inequalities, and enhancing patient experience. Case note review or clinical observation. The Care Quality Commission is the independent regulator of health and social care in England. umentation. A GP is a medical doctor, sometimes called a family doctor. They are usually the first person patients see for their health care, and they help patients to access other services. The consumer champion for both health and adult social care and should be the independent, influential and effective local voice of the public on health issues. An unexpected event that had an actual, or potential, adverse impact on the patient s health or well-being and that a) requires investigation and / or b) could provide learning in order to avoid a recurrence within the service or elsewhere. International normalised ratio Monitor is the independent regulator of NHS Foundation Trusts. Meeting patients, carers and staff. National Institute for Health and Care Excellence. A health or social care organisation that provides services to patients. Quality Standard. See Provider. See Commissioner. An NHS Trust, NHS Foundation Trust or other organisation with management responsibility for the service. West Midlands Quality Review Service. WMQRS Primary Care Services QSs V1.2 20160209 20

APPENDIX 4 PRESENTATION OF EVIDENCE FOR PEER REVIEW VISITS Each Quality Standard reference column includes a box that illustrates how compliance will be reviewed. Background information ing facilities Meeting patients, carers and staff Case note review or clinical observation umentation This means that the information should be included in the background report or self assessment. Reviewers will look for the information while they are visiting the service. These Standards will be discussed with patients, carers and / or staff as appropriate. A few Quality Standards require reviewers to look at case notes or other clinical information. These are policies, guidelines and other documentation that reviewers will need to see. The following table summarises the evidence needed for each Quality Standard. QS Ref. No QS Short Title Background information ing facilities Meeting patients, carers & staff Case note review or clinical observation umentation Illustration of umentation Required NM-101 Service Information Patient information about the service NM-102 NM-103 NM-104 NM-196 Condition-Specific Information Management Plan Review of Management Plan Discharge Information NM-199 Involving Patients and Carers Examples of changes made as a result of feedback NM-201 NM-202 NM-203 Lead Clinician Staffing Levels and Skill Mix Service Competences and Training Plan Competence Framework and Training Plan: Competence framework describing the competences expected for roles within the service. Training and development plan to show how staff will achieve and maintain competences WMQRS Primary Care Services QSs V1.2 20160209 21

QS Ref. No NM- 203A NM-299 NM-301 NM-401 NM- 402A NM-499 NM- 499A QS Short Title Service Competences and Training Plan Anticoagulation Administrative, Clerical and Data Collection Support Services providing Support and Advice to Practices Facilities Equipment Anticoagulation Service IT System IT System Anticoagulation Background information ing facilities Meeting patients, carers & staff Case note review or clinical observation umentation Illustration of umentation Required NM-501 Clinical Guidelines Guidelines: Clinical NM-601 Operational Policy Policy: Operational NM-602 Participation in Local Review and Learning Meetings Meeting notes with attendance NM-701 Data Collection Examples of data showing compliance with the QS NM-702 Audit Audit programme or plan Examples of completed audits, action plans and monitoring. NM-703 NM-798 Audit Information for Commissioners Multi-disciplinary Review and Learning Examples of audit information for commissioners. umentation depends on local arrangements and may include, for example, minutes of review and learning meetings held within the service. NM-799 ument Control Compliance determined from other documentation presented. NZ-499A Computer Software Decision Support for Anticoagulation Services Specification for Computer Software Decision Support and quality assurance NZ-501 Clinical Guidelines Guidelines: Clinical, agreed with relevant local consultant-led service NZ-601 Commissioning of Services Service Specification WMQRS Primary Care Services QSs V1.2 20160209 22

QS Ref. No NZ-602 QS Short Title Local Review and Learning Meetings Background information ing facilities Meeting patients, carers & staff Case note review or clinical observation umentation Illustration of umentation Required umentation depends on local arrangements and may include, for example, minutes of review and learning meetings held locally NZ-703 Quality Monitoring Quality monitoring report NZ-703A Quality Monitoring Anticoagulation Services Quality monitoring report WMQRS Primary Care Services QSs V1.2 20160209 23