4.1 Clinical Governance

Clinical governance is defined in the 1998 consultation document “A First Class Service: Quality in the New NHS”1 and also in 1998 by Scally and Donaldson in the British Medical Journal2 as:

“A framework through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish.”

As clinical governance is based on professional values and concern for others, the sonographer is actively involved in this process of accountability as part of his or her daily activities. By safeguarding high standards of care and seeking to continuously improve its quality, it ensures that health care provision is patient-centred which is central to the concept.

To the sonographer, clinical governance means:

4.2 Acquisition, Archiving And Use Of Ultrasound Data

Ultrasound data refers to ultrasound images, ultrasound reports and request forms. They include images captured and stored in digital, video, X-ray film or thermal paper format(s) and written reports/requests generated either in electronic format or on paper.

Image Recording

The compilation of an appropriate number of annotated images that represent the entire ultrasound examination is good practice as it provides the following:

• support for the written report
• a second opinion to be given on those parts of the examination that have been imaged
• contribution to clinical governance through audit and quality control
• a teaching tool
• evidence that the examination was carried out to a competent standard evidence that the local guidelines were followed

Unless the entire examination is recorded, it must be recognised that the ultrasound image data cannot be fully representative of that examination. All images should have the following demographic and machine information correctly recorded on them:

• Patient identification
• Date of examination
• Hospital/department identification

The sonographer should be aware that the on-screen information is not always reproduced on the recorded images. For example, the safety indices displayed during the real time examination may not be replicated on the accompanying thermal images.

The sonographer should ensure that the local departmental guidelines address the issues of:

• ultrasound data acquisition
• archiving of examination specific ultrasound data in accordance with national guidance
• current legislation including Data Protection and Freedom of Information Acts

(Refer to Section 1.9)

It is the sonographer’s responsibility to ensure that an appropriate number of diagnostic and annotated images is recorded to match the dynamic examination in support of the written report.

Additional Reading

• The Royal College of Radiologists, (2006). BFCR(06)4; Retention and Storage of Images and Radiological Patient Data. London: RCR
• Department of Health, (2006). Records Management: NHS Code of Practice: Parts 1 & 2. London: DH
• British Standards Institute BSI PD 0008, (1999). Legal Admissibility and Evidential Weight of Information Stored Electronically. London: BSI
• Medical Ethics Department. (2004). Taking and using visual and audio images of patients: Guidance from the Medical Ethics Department. London: BMA.
• Committee on Publication Ethics. (2000). The Cope Report. London: BMJ Books.

4.3 Use Of Mobile Telephones And Other Electronic Devices In The Ultrasound Department

The Department of Health (DH) guidance on all aspects of policy concerning the use/misuse of mobile phones and other electronic devices is comprehensive and transparent. The guidance(1) can be used to inform a local written policy on the use of mobile telephones and electronic devices in the ultrasound department.

The Medicines and Healthcare products Regulatory Agency (MHRA) advises that Trusts and Boards do not impose an overall ban on the use of mobile phones. Previous technological evidence may have been misinterpreted and this has led to inconsistencies in the implementation of policy based on this evidence. However, as these electronic devices become more sophisticated and may have photographic capabilities, respect for patient and staff privacy and confidentiality should be maintained at all times.

Only when there is good reason should mobile phones be switched on and used in clinical areas. Trusts and Boards are advised to establish designated areas, clearly sign-posted, where the use of mobile phones is permitted. They are also advised to carry out a risk assessment before a locally defined policy is published.

It must be noted that the DH advice is related to NHS Hospitals only. Sonographers who work in Primary Care, independent treatment centres, the private sector or other areas where medical ultrasound is practised may not be governed by this guidance. It should be the responsibility of all sonographers in these situations to seek out appropriate advice at their workplace and together with the DH recommendations include it in their departmental written guidelines. 

References

1. Department of Health, 2007. Using Mobile Phones in NHS Hospitals. London: Department of Health.

Additional Reading

• http://dh.gov.uk [2] • http://healthcarecommission.org.uk [3] • www.mhra.gov.uk [4]

4.4 Use Of Patient, Staff And Hospital Data For Education And Research

Ultrasound students are required to access, compile and submit all or a part of confidential patient information and ultrasound images to another individual for the purposes of assessment1. This material may include demographic and personal data, clinical details, ultrasound reports and images and may be stored electronically or in paper format. Unless students and their tutors address the appropriate access procedures to use confidential material, assessments may be compromised and patient confidentiality will be breached. These issues are also relevant to sonographers involved in the gathering of ultrasound data for purposes of research.

The following guidelines should be considered:

• agree a local procedure for access and use of confidential material for education or research purposes
• all patients whose cases are to be used for assessment purposes must be asked for their consent prior to the ultrasound examination taking place
• all patients who give prior consent have the right to withdraw their consent at any time before the submission of the assessment
• all patient identification should be removed from documentation and ultrasound images prior to assessment submission or research publication
• a disclaimer should be included in the submission if permission has been given to identify material that could be traced to source • all captured assessment data should be anonymous and electronically stored on equipment within the ultrasound department. This includes draft assignments, work in preparation and research protocols
• a record of data matchings between anonymous and named data sets for search and identification purposes should be retained
• all stored study data should be destroyed on successful completion of the learning episode or research programme
• ethical approval should be sought, and obtained where appropriate, for research studies
• The Data Protection Act (1998) and NHS (2006) guidance will be adhered to at all times 

Additional Reading

• Ethics Committee, (2001) The BMJ’s ethics committee is open for business. British Medical Journal, 322: 1263-1264
• Data Protection Act 1998
• Freedom of Information Act 2000
• Australian Society for Ultrasound in Medicine. (2000) Consent to Ultrasound Scanning for Teaching Purposes. B6: ASUM.
• Sayer, M., Bowman, D., Evans, D., Wessier, A., and Wood, D. (2002). Use of patients in professional medical examinations: current UK practice and the ethicolegal implications for medical education.
• British Medical Journal. 324: 404-407
• Medical Ethics Department. (2004). Taking and using visual and audio images of patients: Guidance from the Medical Ethics Department, London: BMA.
• http://www.asum.com.au/open/home.htm [5]
• http://www.gmc-uk.org [6]

4.5 Guidelines For The Scanning Of Persons For Non-Clinical Purposes

Ultrasound examinations for non-clinical purposes include the scanning of:

• patients for training of medical and non-medical sonographers in the clinical setting
• student and tutor volunteers for skill-based training in the classroom
• models at conferences and workshops in support of presentations
• subjects in research studies to test an hypothesis
• sonographers and application specialists for demonstrating equipment
• patients requesting an examination for which there is no clinical indication

The sonographer should:

• ensure that the ultrasound exposure time is kept to a minimum and does not exceed recommended safety limits
• be aware of the safety policies and procedures, including those for work-related musculoskeletal disorders and recommendations issued by professional bodies, scientific and legislative organisations
• ensure that written local guidelines for non-clinical examinations reflect current guidance and good practice
• discourage, and personally decline, the ad-hoc scanning of local health care and hospital staff for clinical purposes who present without a formal request (Refer to Section 1.9) 

Points of Good Practice

• Appropriate referral pathways should be in place in the event of unanticipated findings, including pregnancy, being discovered during an examination for non-clinical purposes. The patient should be made aware of this policy prior to undergoing the examination and should accept responsibility to act on the finding
• Any person must be fully aware of the nature and purpose of the procedure and the anticipated exposure conditions as they relate to those in normal clinical practice
• Written consent should be obtained from the patient after a full explanation has been given
• The examination should be supervised by a qualified and competent sonographer who is working to a recognised set of standards and who has authorisation to supervise the scanning of volunteers and other patients. It is recommended that the sonographer has professional indemnity for scanning for non-clinical referrals
• The sonographer is expected to be aware of current findings and opinions regarding the safety of all ultrasound examinations, in particular the use of Doppler examinations in pregnancy
• The sonographer must always minimise the ultrasound dose, without compromising diagnostic value, during the examination
• Children under 16 years of age should not participate in non-clinical ultrasound examinations
• Ethical permission must be sought from the local ethics committee for the purposes of research

Additional Reading

• http://www.aium.org/publications/statements/_statementsSelected.asp?stat... [7]
• http://www.bmus.org.publications/pu-volunteers01.asp [8]
• http://www.asum.com.au/open/home.htm [5] • http://www.efsumb.org/efsumb/committees/Safety_Committee/Safety_En/2006/... [9]
• http://www.bmus.org.publications/pu-guidelines01.asp [10]

4.6 Guidelines Relevant To Setting Up A Sonographer-Led Interventional Ultrasound Service

Interventional ultrasound services are classed as an extension of the role of the sonographer and amongst others may include amniocentesis, paracentesis, hystero-contrast-sonography, sono-hysterography, fine needle aspiration of the breast or thyroid, and transrectal prostate biopsy.

When setting up any sonographer-led service, it would be appropriate to make application to extend the sonographer role to the Clinical Lead, Service Manager and Trust or Executive Health Board seeking their approval.

In order to ensure patient and sonographer safety when setting up the new interventional ultrasound service the following is an example of a best practice application.

Evidence of:

• support from a lead medical practitioner
• appropriate training
• insurance/liability cover for the sonographer
• quality assurance and audit programmes
• acceptance by all clinicians that the sonographer is the person to consent patients
• protocol for each individual procedure that the sonographer will complete Additional

Additional Reading

Professional Development and Role Extension

• The College of Radiographers, (2003). Role Development Re-visited: The Research Evidence 2003. London: CoR.
• The College of Radiographers, (2008). Continuing Professional Development: Professional and Regulatory Requirements. London: CoR. http://www.sor.org [11]
• Department of Health, (2000). The NHS Plan 2000. London: DoH. http://doh.gov.uk [12]

Training + Delegation of Tasks

• The Royal College of Radiologists, (1999). Skill Mix in Clinical Radiology. London: RCR
• The Royal College of Radiologists + The College of Radiographers (1998), Inter-professional Roles and Responsibilities in a Radiology Service. London: RCR, CoR. http://www.rcr.ac.uk [13]