Management of Diagnostic Testing and Screening Procedures Policy

Trust Policy Management of Diagnostic Testing and Screening Procedures Policy Purpose Date Version July 2012 2 The purpose of this policy is to ensure that all diagnostic and screening tests undertaken within the Trust are managed to minimise the risk to those tested and to improve outcomes and quality of care. Who should read this document? Staff involved directly or participating in the management of diagnostic testing and screening procedures, within or on behalf of Plymouth Hospitals NHS Trust. Key messages All healthcare practitioners involved directly or participating in the management of diagnostic testing and screening procedures must have the necessary knowledge, skills and competencies required. Clear pathways must be in place that identify how, when and to whom results should be communicated All services undertaking diagnostic and screening tests are required to develop local procedural documents which meet nationally agreed standards. Accountabilities Production Review and approval Ratification Dissemination Compliance Assistant Medical Director for Quality Effective Care Group Medical Director Links to other policies and procedures Patient Safety & Effectiveness Manager Effective Care Group Range of SOPs covering diagnostic testing and screening procedures Adverse Events Policy and supporting SOPs Risk Management Framework Ionising Radiation Safety Policy Version History 1.0 Dec 11 First version of overarching policy 1.1 Dec 11 Amended to reflect IHG Restructure 2.0 July 12 Reviewed in light of 2012/13 NHSLA Risk Management Standards

Last Approval Due for Review July 2012 December 2015 PHNT is committed to creating a fully inclusive and accessible service. Making equality and diversity an integral part of the business will enable us to enhance the services we deliver and better meet the needs of patients and staff. We will treat people with dignity and respect, actively promote equality and diversity, and eliminate all forms of discrimination regardless of (but not limited to) age, disability, gender reassignment, race, religion or belief, sex, sexual orientation, marriage/civil partnership and pregnancy/ maternity. An electronic version of this document is available on the Trust Documents Network Share Folder (G:\TrustDocuments). Larger text, Braille and Audio versions can be made available upon request. Page 2 of 16

Contents Section Description Page 1 Introduction 4 2 Purpose 4 3 Consequences 4 4 Definitions 4 5 Roles and Responsibilities 5 6 Development of Local Procedural Documents 6 7 Risk Assessment 7 8 Monitoring and Reporting Compliance and Effectiveness 7 9 Consultation and Approval 8 10 Dissemination and Implementation 8 11 References 8 Appendix 1 List of Screening Procedures 9 Appendix 2 List of Diagnostic Testing Procedures 10 Appendix 3 Risk Tolerance Matrix 11 Appendix 4 Dissemination Plan 12 Appendix 5 Equalities & Human Rights Impact Assessment 13 Page 3 of 16

1 Introduction The NHS Litigation Authority has identified that the mis-use, or mis-interpretation of test results is a significant risk in the NHS. Arriving at a diagnosis that turns out to be wrong can lead to unintended harm as a result of incorrect treatment. Equally, failure to diagnose a condition when present can cause harm. There are risks that accrue from failure to act on screening and diagnostic test results appropriately. The NHSLA states that Trusts should actively manage these risks, through application of clear levels of responsibility and robust processes to ensure that results are dealt with correctly. This policy provides a structure for locally developed Standard Operating Procedures (SOP) and other procedural documents for diagnostic testing and screening. It sets the requirement for all such local procedures to include details of controls over the process of requesting, reporting, communicating and acting upon the results of testing. It requires local procedures and SOPs to include details of how compliance with those procedures will be monitored and assurance will be gained and reported. All services undertaking clinical diagnostic and screening tests are required to develop local procedural documents, which should direct healthcare staff in relation to their duties and the procedures to be adopted for all diagnostic and screening tests. These will at least meet nationally agreed standards. 2 Purpose The purpose of this policy is to: ensure clear pathways that identify how, when and to whom the results should be communicated. minimise the risk to those tested and to improve outcomes and quality of care. to provide a list of the screening procedures currently undertaken within the Trust; see Appendix 1. to provide a list of the diagnostic tests currently undertaken within the Trust, see Appendix 2. 3 Consequences of not complying with this policy There will be increased risk of patients not receiving effective care There will be increased risk of patients being harmed Patients will not be diagnosed in a timely fashion The Trust will not have appropriate assurance over diagnostic testing or screening procedures 4 Definitions

Diagnostic test a test or measurement that can be used to determine what conditions, diseases or syndromes a patient may currently have or is likely to develop. Screening a process of identifying apparently healthy people who may be at increased risk of a disease or condition. They can then be offered information, further tests and appropriate treatment to reduce their risk and / or any complications arising from the disease or condition. 5 Roles and responsibilities Trust Board and Chief Executive To ensure that adequate systems and arrangements are in place and to provide assurance that all screening and diagnostic testing is carried out in accordance with laid-down procedure. Medical Director The Medical Director is responsible for ensuring that the Trust is delivering screening and diagnostic testing procedures in accordance with relevant best practice, regulations and clinical guidelines. Detailed responsibilities are delegated to the relevant clinical director or lead clinician. Clinical Director / Lead Clinician As the provider of the screening or diagnostic testing service, the clinical director, or lead clinician is responsible for: identifying each screening and diagnostic test that is carried out within their directorate and maintaining up to date SOPs, for each test at an appropriate time frequency. ensuring that full consideration is given to available regulations and guidance, feedback from staff and patients, results from external reviews etc. as part of the process of developing or updating the SOP. The authorship role may be delegated. ensuring that adequate arrangements are in place for quality assurance monitoring and reporting where necessary, compliance with all of the requirements of each screening and diagnostic testing SOP reporting incidents of observed non-compliance with the screening and diagnostic testing, at each stage of the process, including requests for tests and appropriate follow up of reported test results Page 5 of 16 address reported incidents of non-compliance within their directorate. Requesting clinicians As the referrer to the screening programme or diagnostic testing service, the requesting clinician is responsible for gaining assurance that requests for screening and diagnostic tests are appropriate and are acted upon and communicated correctly. Effective Care Group

The Effective Care Group is responsible for: ensuring that it receives assurance of the appropriate delivery of screening and diagnostic tests, through receipt of periodic performance and exception reports from clinical directorates, seeking assurance that risks identified in relation to screening and diagnostic tests are managed and mitigated appropriately and escalated where required, in accordance with the Trust s Risk Management Framework. seeking assurance that incidents, including legal claims and inquest findings are managed appropriately and that any lessons to be learned from incidents are taken into account in future delivery of the service. Radiation Protection Committee Inevitably a number of diagnostic tests and screening procedures involve the use of radiation. The Radiation Protection Committee has specific responsibility for seeking assurance of compliance with the requirements of the Ionising Radiation (Medical Exposure) Regulations. Please refer to the Trust s Ionising Radiation Safety Policy. All members of staff All staff involved directly or participating in the management of diagnostic testing and screening procedures are required to maintain an up to date knowledge and understanding, relevant to their duties, of relevant SOPs for screening procedures and diagnostic tests. Staff are also expected to report all risks identified and reportable incidents witnessed, in line with the Trust s Adverse Events Policy and supporting SOPs. 6 Development of departmental SOPs for diagnostic and screening tests The following section does not apply where formal procedural documentation is required to be written in a specific way, or follow a specific design, as required by a recognised external accreditation agency, or nationally mandated procedure. For this exclusion to apply, however, the scope of the externally mandated procedural record must include the processes of requesting the test and reporting test results. A specific SOP or suite of SOPs must be maintained for each type, or group of alike screening and diagnostic tests. These must identify: the duties and responsibilities for all Trust staff involved in the process; assurance arrangements required for elements of the process that are delivered by organisations and staff external to the Trust; processes for initiating and requesting tests and the recording of this; the process and timescales for receipt of test results and acting upon them, including the process for recording who is informed of the results, how they are informed, quality control monitoring, recording of subsequent actions, follow up and referral; Page 6 of 16

the process and timescales for communicating the results to the patient and recording of this; arrangements for monitoring and reporting compliance with best practice, regulatory, procedural and contractual requirements; and consultation and review arrangements for ensuring the adopted SOP remains up to date and relevant across the Trust. The process of developing the SOP should involve staff who are involved directly in the management of diagnostic testing and screening procedures. The review process should take account of known available professional, clinical and technical evidence and guidance and should consider local experience, from patients and staff. Further guidance on the expected content of each SOP is set out in the template held on the trust documents drive (TRW.CLI.SOP.597.1 Standard Operating Procedure Template for Screening Programmes and Diagnostic Tests) 7 Risk Assessment Each type, or group of alike, screening procedures and diagnostic tests should be risk assessed with reference to the Risk Tolerance Matrix at Appendix 3. The risk assessment may also be supported by analysis of the output of quality assurance and monitoring programmes and analysis of adverse event data. Where the residual risk is assessed as Moderate, Significant or Serious then the risk must be entered onto the Trust s risk management system Datix and managed in accordance with the Trust s Risk Management Framework. The aim of this risk assessment is to identify, manage and reduce the risks associated with the screening programme or diagnostic test as a whole. Risk assessment is also conducted for each individual patient referred for medical imaging. The Ionising Radiation Safety Policy requires Clinical Directors to ensure that Departmental Operating Procedures are implemented which include referral criteria and justification criteria for any procedure that the Operators are entitled to authorise. In addition, the Procedure for Carrying out Risk Assessments in the Medical Imaging Directorate requires Consultant Radiologists to assess and record the risks of the clinical services that they are offering and inform the patient of the risks as part of the consent process. 8 Monitoring and reporting compliance and effectiveness Compliance with this Policy including a review of the list of diagnostic tests and screening procedures undertaken on our patients will be reviewed on a six monthly basis by the Assistant Medical Director for Quality and the Effective Care Group who will ensure that actions are documented and implemented to address any issues arising. The group will review the list of diagnostic and screening tests and seek assurance for each diagnostic test or screening procedure undertaken that: SOPs have been designed and agreed by the lead clinician Page 7 of 16

SOPs have been approved by the local specialist group and ratified by the relevant individual (senior clinician or Director grade staff) against this policy Once approved and ratified, the SOP has been uploaded as complete on the SOP database together with planned future review date Plans for monitoring compliance with the SOP have been detailed on the SOP database. Risk assessments have been undertaken with the outcome of assessment recorded on the SOP database. Any residual risk assessed as Moderate, Significant or Serious has been managed and escalated appropriately. The output of this review will be reported to Safety and Quality Committee. 9 Consultation and approval The design and process of review and revision of this policy document will comply with the Trust s formal policy on policy and procedural documents (The Development and Management of Trust Wide Documents). The review period for this policy document is set as four years from the date it was last ratified, or earlier if developments within or external to the Trust indicate the need for a significant revision to the policy. This document will be approved by the Effective Care Group and ratified by the Medical Director. Non-significant amendments to this policy document may be made, under delegated authority from the Medical Director, by the nominated author. These must be ratified by the Medical Director and should be reported, retrospectively, to the Effective Care Group. Significant reviews and revisions to this policy will include an extensive consultation with all senior clinicians in the Trust. All directors of the Trust will be invited to contribute to proposed revisions of the policy. For non-significant amendments, informal consultation will be restricted to directors and clinicians who are directly affected by the proposed changes. 10 Dissemination and implementation Following approval and ratification, this policy will be published in the Trust s formal documents library and all staff will be notified through the Trust s normal notification process, currently the Vital Signs electronic newsletter. All senior clinicians will be sent an electronic copy of this ratified document. Document control arrangements will be in accordance with the Trust s formal policy on policy and procedural documents. 11 References The following documents are referred to in this policy, or provide additional sources of reference material: Page 8 of 16

NHSLA Risk Management Handbook, 2011/12. February 2011. NHS Litigation Authority, NHSLA Risk Management Standards for NHS Trusts providing Acute, Community or Mental Health & Learning Disability Services and Independent Sector Providers of NHS Care, 2011/12. NHS Litigation Authority, January 2011. Page 9 of 16

List of Screening Procedures Appendix 1 National Cancer Screening: Breast Cancer Bowel Cancer National Screening (non cancer): Diabetic Retinopathy Maternal Infectious Diseases 18+0 to 20+6 week Fetal Anomaly Screening Programme First Trimester Downs Examination of the newborn Newborn Bloodspot Screening: Cystic Fibrosis / MCADD Screening / PKU / Thyroid / Sickle Cell / Thalassaemia Newborn Hearing Infectious Diseases: MRSA / MSSA Tuberculosis

List of Diagnostic Testing Procedures Appendix 2 IMAGING ENDOSCOPY PATHOLOGY PHYSIOLOGY CT Colonoscopy Cytology Cardiac physiology and electrophysiology Angiography Gastroscopy Haematology Respiratory Physiology MRI Flexi - Sigmoidoscopy Histopathology Neurophysiology Fluoroscopy Capsule Endoscopy Biochemistry Gastro-intestinal Physiology PET 24hr Oesophageal ph Studies POCT Urodynamics X Ray Oesophageal Manometry Immunology Vascular Studies Ultrasound Colposcopy Microbiology Ophthalmic Hysteroscopy Audiology Arthroscopy Nasendoscopy Cytoscopy

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Risk Tolerance Matrix Appendix 3 Impact Risk to Patients Risk to Staff Risk to Business Consider from three points of view: Consider from two points of view: 1. Complexity: The degree of intervention required to perform the screening procedure or diagnostic test or risk of mortality associated with undertaking the screening procedure or diagnostic test. 2. Timing: The potential impact of delayed diagnosis. 3. Accuracy: The potential impact of missed diagnosis. 1. The resource required to deliver a safe service. 2. The risks to staff delivering the service e.g. lack of clinical details resulting in samples being handled in laboratories at the wrong biological containment level, thereby placing laboratory staff at increased risk of infection. Catastrophic Avoidable death of patient due to significantly increased mortality rate associated with the screening or testing procedure. Avoidable death of patient due to missed or delayed diagnosis. Long term loss of several key staff, resulting in long term loss of service capacity. Long term loss of key service line, with serious failure to deliver contracted commitments. Long term adverse national publicity and loss of public confidence. Severe Serious or permanent harm to patient e.g. due to delayed follow up, unwarranted surgical intervention as a result of misdiagnosis or unjustified exposure to high dose CT. Long term unsafe staffing levels. Short term loss of key staff, resulting in short term loss of service capacity. Medium term loss of service line, or key service element, with significant failure to deliver contracted commitments. Short term adverse national publicity, with ongoing local publicity and negative impact on public confidence. Moderate Injury, or harm, requiring clinical intervention. Loss of numbers of staff, resulting in restrictions to service capacity. Short-term loss of service line, or key service element, with adverse impact on delivery of contractual commitments. Short term adverse local publicity. Minor Injury, or harm, requiring minor clinical intervention. Loss of small numbers of staff, resulting in pressure on service capacity. Restriction to service line, or service element. Insignificant Minimal impact requiring no clinical intervention. Pressure on staff numbers.

Dissemination Plan Appendix 4 Core Information Document Title Date Finalised August 2012 Dissemination Lead Previous Documents Previous document in use? Action to retrieve old copies. Dissemination Plan Policy for the management of diagnostic testing and screening procedures Paul McArdle, AMD for Quality / Amelia Brooks Patient Safety & Effectiveness Manager Yes Electronic archived by Information Governance Team Recipient(s) When How Responsibility Progress update All Trust Staff August 2012 Vital Signs Paul McArdle / Amelia Brooks All in Department Clinical Professions and Endoscopy Consultants and Clinicians August 2012 Electronic Paul McArdle / Amelia Brooks August 2012 Electronic Paul McArdle / Amelia Brooks All Clinical Directors August 2012 Electronic Paul McArdle / Amelia Brooks

Equalities and Human Rights Impact Assessment Appendix 5 Core Information Manager Directorate Francis Luscombe, AMD for Quality Trustwide Date 14/12/2011 Title What are the aims, objectives & projected outcomes? Scope of the assessment Policy for the management of diagnostic testing and screening procedures Collecting data Race Religion Disability Sex Gender Identity Sexual Orientation Age Socio-Economic Human Rights What are the overall trends/patterns in the above data? Specific issues and data gaps that may need to be addressed through consultation or further research Involving and consulting stakeholders This is mitigated as the policy can be made available in alternative languages. The document has no impact in this area This is mitigated as the policy can be made available in alternative formats. The document has no impact in this area The document has no impact in this area The document has no impact in this area The document has no impact in this area The document has no impact in this area The document has no impact in this area Overall patterns and trends have not been identified but these will be monitored via the. Page 15 of 16

Internal involvement and consultation The following internal individuals have been consulted in reviewing this Policy: Clinical Governance Leads Clinical Directors Clinical Governance Steering Group External involvement and consultation Impact Assessment Overall assessment and analysis of the evidence No external consultation. Completing this Equality Impact Assessment has not identified any issues of particular concern. The policy is not considered to have the potential to cause unlawful discrimination. No significant adjustments are required to the policy. Action Plan Action Owner Risks Completion Date Progress update Page 16 of 16