Diagnostic Testing and Screening Policy Version 1 Name of responsible (ratifying) committee Senior Clinical Management Team Date ratified 15 February 2012 Document Manager (job title) Diagnostic Imaging Manager / Consultant Histopathologist Date issued 8 March 2012 Review date February 2013 Electronic location Management Policies Related Procedural Documents Policy for the Management of Adverse Incidents and Near Misses; Policy for the Management of SIRIs; Radiological Policies and Procedures. Key Words (to aid with searching) In the case of hard copies of this policy the content can only be assured to be accurate on the date of issue marked on the document. For assurance that the most up to date policy is being used, staff should refer to the version held on the intranet Diagnostic Testing Policy. (Review date: February 2013 Issue 1 8 March 2012 Page 1 of 11 CONTENTS QUICK REFERENCE GUIDE ...................................................................................................... 3 1. INTRODUCTION.......................................................................................................................... 4 2. PURPOSE ................................................................................................................................... 4 3. SCOPE ........................................................................................................................................ 4 4. DEFINITIONS .............................................................................................................................. 5 5. DUTIES AND RESPONSIBILITIES ............................................................................................. 5 6. PROCESS .................................................................................................................................. 7 7. REFERENCES AND ASSOCIATED DOCUMENTATION ........................................................... 9 8. EQUALITY IMPACT STATEMENT .............................................................................................. 9 9. MONITORING COMPLIANCE ................................................................................................... 10 Appendix A: Reporting of Results ……………………………………………………………………….11 Diagnostic Testing Policy. (Review date: February 2013 Issue 1 8 March 2012 Page 2 of 11 QUICK REFERENCE GUIDE For quick reference the guide below is a summary of actions required. This does not negate the need those involved in the process to be aware of and follow the detail of this policy. Diagnostic Test / Screening Requested by Referring Healthcare Professional Referrer makes note of test / examination request in patient’s medical records Booking and scheduling processes as required in line with local processes If rejected, requestor notified Diagnostic Test / screening performed (or amended under IRMER for radiology requests) and reported Results produced and provided in accordance with local policies and protocols Unexpected findings escalated in accordance with local policies and protocols Results viewed, acted upon accordingly and recorded by requester Note: all requesting clinicians, both medical and nonmedical, are responsible for reading and acting upon the results of all tests that they request Patients informed of all results by requestor or nominated deputy, who should document that discussion Diagnostic Testing Policy. (Review date: February 2013 Issue 1 8 March 2012 Page 3 of 11 1. INTRODUCTION The appropriate requesting and follow up of diagnostic and/or screening tests is an integral part of patient treatment and also an area prone to error. Therefore it is important for patient safety, quality and efficiency that these processes are managed well and that they perform reliably. As a central part of clinical care, the correct management of diagnostic testing can help to ensure that: Procedures are requested in line with patient clinical need, safety and consent All requests are processed and can be tracked from request to conclusion The results of tests lead to the correct diagnosis and patient care Results are viewed, acted upon accordingly and recorded The risk of misdiagnosis or failure/delay in diagnosis is minimized Actions are taken to continuously improve patient outcomes and quality of care 2. PURPOSE This policy covers the management of all diagnostic and screening tests/examinations from request to reporting and results acknowledgement. Whilst general principles are outlined, clinical areas must develop their own procedure specific documents in order to standardize local working practices. It will: Ensure staff responsibilities and procedures for requesting all diagnostic and screening tests / examinations are stated clearly in order to minimize the risk to patients and improve patient outcome and quality of care Outline expectations and provide Trust-wide guidance in relation to the development of local detailed policies, protocols or standing operating procedures relating to the requesting, reporting, results recording, and communication of the results of the tests / examinations 3. SCOPE This policy applies to all permanent, locum, agency, bank and voluntary staff of Portsmouth Hospitals NHS Trust, the MDHU (Portsmouth) and Carillion, whilst acknowledging that for staff other than those directly employed by the Trust the appropriate line management or chain of command will be taken into account. It includes the management of all diagnostic and screening tests/examinations including, but not limited to: Radiological tests: Plain Film; Fluoroscopy; Ultrasound; CT; MRI; Nuclear Medicine ECGs Pathology tests/examinations from all disciplines, including: microbiology; haematology; biochemistry; histopathology; cytology, molecular biology Screening tests, including: bowel screening; breast screening Note: it does not cover daily observational measurements such as heart rate, blood testing nor self-testing by patients ‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’ Diagnostic Testing Policy. (Review date: February 2013 Issue 1 8 March 2012 Page 4 of 11 4. DEFINITIONS Acknowledger: any registered healthcare professional, either the original requester or delegated person who become responsible for the patient’s continuing management Diagnostic test: a diagnostic test is used to confirm whether or not there is the presence of certain diseases or conditions. These tests often involve health risks and their use must outweigh these risks. Examples include x-rays and cross-sectional imaging scans. Justified (for radiological procedures/scans): formal IR(ME)R term for approval by a recognised practitioner for any procedure involving the use of ionizing radiation to proceed on the grounds that it is ‘clinically justified’ i.e. there is net benefit for the patient. ICE: electronic system by which some pathology tests are requested and reported NPSA Safer Practice Notice: a publication from the National Patient Safety Agency to which all NHS trusts must respond and take action according to the published recommendations Practitioner: IR(ME)R term for any appropriately qualified medical or dental or healthcare professional who is entitled to take responsibility for approving an individual procedure involving the use of ionizing radiation Referrer: IR(ME)R term for any appropriately qualified medical or dental practitioner or healthcare professional requesting an imaging procedure involving the use of ionizing radiation (otherwise known as a ‘requester). Reporter: any appropriately qualified medical or dental or healthcare professional who interprets the diagnostic test results and produces a report for the healthcare professional to act upon Requester: any registered healthcare professional who requests a diagnostic test / examination. Royal College of Radiologists (RCR): the college responsible for the standards of communication of critical, urgent and unexpected significant radiological findings Screening: a process, often part of a programme, to identify the personal risk of developing a disease or condition within well people e.g. bowel and breast screening 5. DUTIES AND RESPONSIBILITIES Requester is responsible for: Adhering to all local policies / protocols Obtaining patient consent, as appropriate to the proposed test Ensuring requests for investigation / test is made appropriately by including: o Patient demographic details i.e. surname, forename, date of birth, NHS number o Details of requester, including contact information o Date and time o Clinical details o Details of treatment or drug therapy o Investigation required o Indication of urgency Failure to provide this information may lead to a delay or rejection of the request Ensuring tests are only requested when the result will influence the diagnosis or management of the patient and that the benefit of undertaking the test outweighs any associated risks Diagnostic Testing Policy. (Review date: February 2013 Issue 1 8 March 2012 Page 5 of 11 Receiving the results of the diagnostic test results. Results may be provided electronically on the PACS and RIS systems or, for General Practitioners, on paper Recording the results in the patient’s medical records – even if the results are normal Taking (and recording) any action required following receipt of the test results Ensuring the results of the test are communicated effectively Note: all requesting clinicians, both medical and non-medical, are responsible for reading and acting upon the results of all tests/examination that they request. Reporter is responsible for: Ensuring local procedures / protocols are followed (Appendix A) Validating and authorizing the results in a timely fashion Where appropriate, providing advice on when tests should be repeated and/or alternative imaging is justified. Note: radiographs for inpatient and outpatient referrals will not be reported unless specifically requested by the referrer. Clinical Service Centre (CSC) Governance Leads are responsible for identifying all clinical services that meet the definition of a ‘diagnostic or screening test’ and ensuring that: Appropriate policies / procedures / standard operating procedures are in place A nominated individual is responsible for the implementation and review of any local documents The local document follows the requirements of this policy The local documents are up to date and reviewed in line with their review date Appropriate arrangements are in place for the audit/monitoring of local procedures and that these are cross-referenced to the annual CSC / Specialty audit plans Nominated Lead for Each Local Document are responsible for ensuring: Staff are aware of the local procedures and that there is evidence of cascade to staff Implementation of the requirements of the local procedures, demonstrable by presence in daily practice of each of the key staff groups affected Ratification of agreed local procedures by a suitable committee / group as agreed with the CSC Governance Lead Reviewing and updating local procedures as and when clinical services or practices change Effectiveness of the local procedures is monitored in accordance with the requirements set out in the documents themselves Local procedures take into account any external bodies which have a role in the effective management of systems to provide and manage diagnostic testing or screening. Diagnostic Testing Policy. (Review date: February 2013 Issue 1 8 March 2012 Page 6 of 11 6. PROCESS 6.1 Summary Diagnostic Test / Screening Requested by Referring Healthcare Professional Referrer makes note of test / examination request in patient’s medical records Booking and scheduling processes as required in line with local processes Diagnostic Test / screening performed (or amended under IRMER for radiology requests) and reported If rejected, requestor notified Imaging results Are posted onto PACS/RIS and are available to internal referrer to view GPs are notified in hard copy Screening results Are posted onto Apex and ICE GPs are notified electronically Unexpected findings escalated in accordance with local policies and protocols Results viewed, acted upon accordingly and recorded by requester Note: all requesting clinicians, both medical and nonmedical, are responsible for reading and acting upon the results of all tests that they request Patients informed of all results by requestor or nominated deputy, who should document that discussion For full details of all pathology services, sample taking, testing and turnaround times, follow pathology. For full details of imaging services, follow diagnostic imaging Diagnostic Testing Policy. (Review date: February 2013 Issue 1 8 March 2012 Page 7 of 11 6.2 Guidelines for the development of local policies, procedures and standard operating procedures The following must be incorporated as a minimum in local procedural documents relating to diagnostic or screening tests 6.2.1 Process for requesting of tests A standardized procedure for requesting to include: o o o o o o 6.2.2 Responsibilities and authorization of requesters and practitioners – including arrangements for training, if required Documented arrangements for: o o o o 6.2.3 The procedure for authorization (including any training) of requesters and those undertaking test procedures An outline of which specific skills/competencies are required to interpret results of the test and how this will be overseen Responsibilities of requesters to adhere to standard operating procedures or equivalent protocols Arrangements to ensure diagnostic/screening tests and procedures cannot be requested and/or undertaken by unauthorized healthcare staff Interpretation and communication of test results Documented arrangements to include: o o o o o o o 6.2.4 Who may and who may not request The medium to be used (e.g. IT system/paper) An outline of the key information required e.g. urgency, allergies, investigation requested Patient ID check procedure (including, where appropriate, labeling of scans The process for ensuring that informed consent is obtained if required Any alternate processes from the above standard procedure e.g. specific emergency situation Acceptable media for communicating tests results (e.g. IT system/paper) All relevant acceptable methods / standards for communication of results (e.g. key words, read-back procedures) Processes in place to ensure the requester is aware of the Status of their request Results of their request Acceptable timescales for the communication of results to the requester Whether an interpretation of the result will be provided to the requester Handover arrangements / requirements where the patient is transferred between healthcare professionals / locations, including out of hours working How the patient will be made aware of the test results; giving due consideration to confidentiality, sensitivity and specific needs of the patient Procedures for acting on results of tests An outline and definition of any categories of result that determine the type or timeliness of action required e.g. critical findings, normal result The responsibilities of / subsequent actions required by the: o Requester Diagnostic Testing Policy. (Review date: February 2013 Issue 1 8 March 2012 Page 8 of 11 o 6.2.5 The target timescales within which actions should be taken Documentation / audit trail to be monitored All documentation/audit trail instructions must be in line with Trust records management policy Documented arrangements for the recording of diagnostic/screening test results should include robust processes for ensuring that the following are recorded in the designated media o o o o o 6.2.6 Professional or department providing the result, report or result interpretation Time, date and individual informed of the result receipt Whether the result should be filed in the patient’s medical records and, of so, how this information will be transferred from the medical device Management plan / identified actions Whether the patient informed The method of communication used e.g. face to face, telephone call, letter Monitoring effectiveness Each local procedure should outline plans to monitor compliance and address any required issues. As a minimum this should include: o o o o o Who will perform the monitoring The frequency of monitoring Auditable standards and/or key performance indicators The group to whom the audit will be reported Responsibilities for addressing any shortfalls 7. REFERENCES AND ASSOCIATED DOCUMENTATION External National Patient Safety Agency, Safer Practice Notice 16 2007 – Early Identification of Failure to Act on Radiological Imaging Reports Royal College of Radiologists – Standards for Communication of Critical, Urgent and Unexpected Significant Radiological Findings (June 2008) Royal College of Radiologists – Standards for a Results Acknowledgement System (February 2010) IRMER 2000 and IRMER regulations National Patient Safety Agency (2004) Right Patient, Right Care The Ionising Radiation Regulations Internal Policy for the Management of Serious Incidents Requiring Investigation Policy for the Management of Adverse Incidents and Near Misses Pathology diagnostic imaging 8. EQUALITY IMPACT STATEMENT Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. This policy has been assessed accordingly Diagnostic Testing Policy. (Review date: February 2013 Issue 1 8 March 2012 Page 9 of 11 9. MONITORING COMPLIANCE As a minimum the following elements will be monitored to ensure compliance Minimum requirement to be monitored Lead Tool Frequency of Reporting of Compliance Action to be taken following the diagnostic test results, including time scales: 100% of appropriate action and time scales Clinical Director /Audit Lead Random audit of 50 inpatient and outpatient records Annually Consultant Histopathologist/ Audit Lead Random audit of 50 inpatient and outpatient records Annually Reporting arrangements Lead(s) for acting on recommendations Policy audit report to: Clinical Director Diagnostic Imaging / CSC Heads of Governance Radiology audit meeting Process for recording who is informed of the diagnostic test results: appropriate recording in 100% of cases Actions to be taken following the screening results: 100% of appropriate action and timescales Process for recording who is informed of the screening results: appropriate in 100% of cases Diagnostic Testing Policy. (Review date: February 2013 Issue 1 8 March 2012 Policy audit report to: Page 10 of 11 Pathology Department meeting audit Clinical Directors Pathology Department / CSC Heads of Governance Appendix A Reporting of Results 1. REQUESTS SUBMITTED MAIN RADIOLOGY DEPARTMENT 1.1. Timescales Timescales for reporting and issuing of results are published on the radiology dashboard 1.2 2. Inpatients within 24 hours Outpatients within 48 hours GP referrals within 7 days Emergency Department within 1 working day Delivery of results Results are posted onto PACS or RIS: available for referrer to view General Practitioners are notified in hard copy Clinically serious or extreme results e.g. cancers/trauma, will be alerted to the referrer by telephone REQUESTS SUBMITTED TO PATHOLOGY 2.1 2.2 Timescales Timescales for turnaround of test results are timed from when samples are received in the laboratory Emergency Department within 1 hour Urgent within 2 hours Routine one day Complex and/or specific tests will be reported in accordance with Pathology Handbook INSERT LINK Delivery of results Results are posted onto Apex and ICE: available for internal referrer to view General Practitioners are notified electronically Clinically serious or extreme results e.g. cancers/trauma, will be alerted to the referrer by telephone For details of pathology turnaround times, follow pathology. For details of imaging services, follow diagnostic imaging Diagnostic Testing Policy. (Review date: February 2013 Issue 1 8 March 2012 Page 11 of 11