quality assurance and verification division · qav010/2016 summary report 5 3. methodology the...

Quality Assurance and Verification Division

Healthcare Audit Report

Audit of the justification process in diagnostic radiology

Audit Reference Number: QAV0102016

Summary Report

QAV010/2016 Summary Report 1

Title Audit of the justification process in diagnostic radiology

Number QAV0102016

Timeframe 26 January 2017 – 30 June 2017

Team Members

Ms. Catherine Timoney, Healthcare Auditor, Quality Assurance and Verification Division (QAVD) (Lead Auditor)

Ms. Mary Greene, Healthcare Auditor, QAVD (Co-Auditor)

Ms. Grainne Heffernan, Healthcare Auditor, QAVD (In training)

Approved by Mr. Patrick Lynch, National Director, QAVD

Context Expert Ms. Bernadette Moran, Radiographic Advisor to the Medical Exposure Radiation Unit

Source of Evidence

Site Visits: Date

Mater Misericordiae University Hospital (Pilot Site)

01 February 2017

Hermitage Medical Centre 02 March 2017

Cork University Hospital 15 March 2017

Our Lady’s Hospital, Navan 22 March 2017

University Hospital Kerry 05 April 2017

Galway Clinic 10 May 2017

Mayo University Hospital 22 May 2017

Final Report Distribution

Date: 17 July 2017

Name Title

Mr. Patrick Lynch National Director, QAVD

Mr. Liam Woods National Director, Acute Hospitals

Ms. Cora Mc Caughan Assistant National Director, Healthcare Audit, QAVD

Ms. Mary Day CEO, Ireland East Hospital Group

Mr. Maurice Power CEO, Saolta Hospital Group

Mr. Gerry O Dwyer CEO, South/South West Hospital Group

Mr. Eamonn Fitzgerald CEO, The Hermitage Medical Centre

Mr. Joe O Donovan CEO, The Galway Clinic

Ms. Janet Wynne Manager, Medical Exposure Radiation Unit

Ms. Bernadette Moran Radiographic Advisor to the Medical Exposure Radiation Unit


Contents

ABBREVIATIONS ......................................................................................................................................... 3

1. BACKGROUND / RATIONALE ................................................................................................................. 4

2. AIM AND OBJECTIVES .......................................................................................................................... 4

3. METHODOLOGY ................................................................................................................................. 5

4. FINDINGS .......................................................................................................................................... 5

5. CONCLUSION ..................................................................................................................................... 9

6. RECOMMENDATIONS .......................................................................................................................... 9

APPENDIX A: SITE RECOMMENDATIONS ........................................................................................................ 11


ABBREVIATIONS

CT Computed Tomography

HERCA Heads of the European Radiological Protection Competent Authorities

MERU Medical Exposure Radiation Unit

PIC Practitioner in Charge

PPPG Policy, Procedure, Protocol and Guideline

QAVD Quality Assurance and Verification Division

SI Statutory Instrument

TOR Terms of Reference


1. BACKGROUND / RATIONALE

The Template for Developing a Patient Radiation Protection Manual was published by the Medical Exposure Radiation Unit (MERU) in 2013 (hereafter referred to as the MERU manual1). The MERU manual was developed to support the practical application of Statutory Instrument (SI) 4782 for the safe and optimal use of medical ionising radiation. By adapting and using the manual, the service provider has an assurance that they have arrangements in place to comply with the legislative obligations of SI 478/303/459 and to inform continuous improvement and ensure patient safety. Section 5 deals with patient protocols and standards including justification.

Currently, the Heads of the European Radiological Protection Competent Authorities (HERCA) are conducting a review of the justification process3. HERCA brings together 56 radiation protection authorities from 32 European countries. These authorities develop national legal frameworks for the safe use of ionising radiation. HERCA requested that the European competent authorities conduct a series of inspections/healthcare audits in radiology departments on the justification process. The goal of this HERCA initiative is to monitor to what extent the justification process is put into practice in diagnostic radiology across Europe and to identify potential routes for improvement. MERU was required to distribute the HERCA questionnaire on the justification process to all radiological facilities in the Republic of Ireland. The healthcare audit team used aspects of this data collection tool on their site visits.

Justification is one of three radiation protection principles of the International Commission for Radiological Protection. Individual medical exposures must be justified in advance. Justification requires that the benefit of each medical imaging procedure outweighs the possible risk caused by radiation exposure. The justification process requires input and verification to be performed by different health care professionals. This healthcare audit focused on the justification process and compliance with the justification principle4 as outlined in section 5 of the MERU manual.

2. AIM AND OBJECTIVES

The objectives of this audit were to:

1. Confirm that selected locations have governance structures, policies, procedures, protocols and guidelines (PPPGs) in place that support the justification process.

2. Confirm that selected locations are following the justification principle as outlined in section 5 of the MERU manual.

3. Identify any audits completed and training/education provided on the justification process.

4. Identify areas of good practice.

1 The MERU manual was developed to support the practical application of the safe and optimal use of medical ionising radiation for patients. It was designed to be a working document to which locations will add local PPPGs and adapt for their own needs.

2 Statutory Instrument 478 addresses the protection of individuals (patients) against the dangers of ionising radiation in relation to medical exposure. SI 303/459 are addendums to SI 478.

3 The justification process is a clinical undertaking to assess the benefit of exposing a patient to medical ionising radiation against the risk of the radiation dose involved in that exposure. It is a decision making process which is essential to good medical practice and individual patient safety.

4 The principle of justification is benefit versus risk, i.e., the benefit of the medical ionising radiation is expected to outweigh the risk of the radiation dose required.


3. METHODOLOGY

The audit was conducted through site visits to a sample of radiology departments. At the request of MERU the sample included six predetermined sites. A pilot site visit to a radiology department took place to test the audit tool prior to implementation at the selected locations and following this, amendments to the audit tool were made. Evidence of compliance was determined by:

A request for evidence to obtain details of the six site’s internal governance structures, a copy of the local justification policy/procedure and other relevant PPPGs supporting the justification process.

A retrospective on-site audit of 10 diagnostic radiology request forms randomly selected from examinations performed on the last working day prior to the site visits. The sample size was dictated according to the instructions laid down in the HERCA data collection tool which was used when reviewing the diagnostic request forms.

An external radiation protection context expert joined the audit team to give advice on any clinical and technical aspects found in the evidence submitted and reviewed on-site. Each location was informed of this in advance of the audit.

During the site visits, the audit team met with key staff to discuss the evidence returned, any gaps found and to assess implementation of the justification process and compliance with the justification principle as outlined in section 5 of the MERU manual.

An exit meeting to discuss the findings from the site visits was held with the site liaisons and other relevant staff.

A draft report was prepared and issued to each site for review of factual accuracy and management comment.

4. FINDINGS

Governance Structures

All sites had developed their Radiation Safety Procedures (hereafter referred to as the local rules). Local rules are a requirement of the licence issued by the Environmental Protection Agency/Office of Radiological Protection5. Four sites had referenced the requirements of SI 1256/478/459/303 in their local rules whilst the remaining two sites referenced SI 125 only.

At three sites the local rules highlighted that the ultimate responsibility for radiation protection rested with the Chief Executive Officer, license holder or hospital authority and that this responsibility was delegated to each head of department. Relevant to the audit objectives, four sites highlighted that no practice involving the use of ionising radiation would be adopted unless it was likely to produce a net benefit to the patient.

All sites confirmed that they had a practitioner in charge (PIC), radiation safety officer and a radiation protection advisor in place. The local rules for two sites contained descriptions of the roles and responsibilities of the PIC, radiation safety officer and radiation protection advisor; however in three sites this was not attached for the position of the PIC. In the final site, these roles and responsibilities were documented in the justification procedures.

5 Now known as the Office of Radiation Protection and Environmental Monitoring.

6 SI 125 lays down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation.


At two sites, in the local rules the following statement was found “Only radiodiagnostic practices which have been approved by the medical and dental councils shall be allowed. Any new practice which has not been approved yet, can be authorised by a radiologist when of the opinion that such a procedure is warrented. A written note to this effect is to be submitted to the Radiation Safety Committee (RSC). Practices which have been disapproved by the medical and dental councils are not allowed”. The audit team, in consultation with the context expert, found that this statement was both contradictory and confusing and required attention for clarification purposes. A recommendation was issued to both sites requesting that this statement be revised.

Additionally, although outside the scope of the objectives of this audit, the audit team found that a section of the local rules at one site referred to reporting patient radiation incidents/near misses to the National Radiation Safety Committee. A recommendation was issued to this site requesting that this section of the local rules be revised to reflect the current practice of reporting patient radiation incidents/near misses to MERU, as per the guidance provided in section 3 of the MERU manual.

All sites confirmed that they had established radiation safety committees which met at a minimum twice yearly. Organograms were submitted which displayed the reporting and governance arrangements of the committees and the audit team can confirm that at all sites appropriate structures were in place as referred to in SI 478. A review of the terms of reference for the committees showed that they were reponsible for:

Reviewing and ensuring the safe use of ionising radiation, including justification,

Monitoring compliance with SI 125/478/303/459, and

Ensuring compliance with the licensing conditions of the Environmental Protection Agency/ Office of Radiological Protection.

In addtion, the current membership was listed which reflected multidisciplinary, interdepartmental and in four cases inter-hospital working.

MERU Manual

The MERU manual is a working document to which locations add their local PPPGs. All six locations confirmed that the MERU manual was available and accessible to staff electronically and/or in hard copy. At five locations, the MERU manual was a working document with all relevant local PPPGs added appropriately, however, at the remaining location the MERU manual was not populated with the relevant local PPPGs.

PPPGs

The following presents a summary of the findings of those PPPGs most relevant to the justification process:

Justification: Three sites had developed individual justification procedures. These procedures reflected that diagnostic radiographic examinations were only to be scheduled and performed based on complete and accurate clinical information and when they had been medically justified. The remaining three locations did not have a specific procedure on justification. However, in one location the local rules included details of justification for Computed Tomography (CT) examinations. In the remaining two locations the requirement for justifying X ray procedures was referred to in other PPPGs.

Vetting, Approval and Rejection of X Rays: One site had this policy which identified the practitioner responsible for reviewing referrals in different modalities.


Comforters and Carers Policy: Two sites had developed a comforters and carers policy. Three sites recorded when staff acted as comforters and carers and monitored the doses they were exposed to.

Patient Identification Policy: All sites had developed a patient identification policy.

Irradiating a Female of Childbearing Age: All sites had developed a policy in this area.

Nurse Prescribing for Requesting X Rays: In five sites nurses had authority to prescribe X rays; each site had developed policies and protocols in this area.

Specific policies on radiology work instructions: Four sites had developed policies/protocols on radiology work instructions.

At the site visits, the audit team was informed that plain films X rays were routinely justified by radiographers. This practice has evolved from implied delegation and the audit team found no documentary evidence of formal delegation from the radiologist to the radiographer.

Section 5 of the MERU manual provides a definition of justification as outlined in SI 478, and that in Ireland the practitioner and the prescriber have clinical responsibility for justification. A definition of what constitutes clinical responsibility is also provided. It is acknowledged that while the practitioner is clearly assigned clinical responsibility for the medical exposure, which includes justification, the prescriber does have some responsibilities in this area and the details of these, as laid out in articles 7.11 and 7.12 of SI 478, are also provided. In addition, the section provides guidance for referrers and lists a set of prompt questions which are recommended to be considered by referrers for each radiological investigation using ionising radiation. However, section 5 does not specifically state that facilities using medical ionising radiation must have a procedure in place outlining the specific requirements in relation to local justification processes. Therefore, although three facilities did not have a specific procedure in place to guide the local justification process, it is acknowledged that the absence of guidance in this regard within the MERU manual may have been a contributory factor.

Referral Guidelines

All six locations informed the audit team that they had made available referral guidelines for the justification of X ray procedures. Five locations stated that they used the Royal College of Radiologists Referral Criteria Guidelines7 (iRefer). The remaining location was using the European Commission Protection 118 Referral guidelines for imaging (2000) to justify radiological examinations. These guidelines are outdated and have been superseded by the iRefer guidelines which are recommended for use in section 5 of the MERU manual.

Review of Referral Documentation

To ensure appropriate justification for radiology procedures, evaluation of request forms was completed at all six sites. All sites had an electronic radiology system where all paper documentation was scanned. In order to assess justification, the audit team used the criteria identified in the HERCA data collection tool. The audit team randomly selected 10 referral documents from those examinations performed at the six locations on the previous working day prior to the site visit. All sites were found to be fully compliant with the following HERCA criteria:

Referral available prior to examination

Patient Identification on referral

7 The iRefer guidelines for medical imaging provide physicians with information on which procedure is most likely to yield the most informative

results and whether another modality is equally or more effective and therefore more appropriate.


Patient’s date of birth on referral

Referrer identified

Contact information of referrer available

Identity of the origin of the referrer recorded, e.g., hospital clinician /GP /others

Clinical details / data available

Signature of referrer

Clinical questions asked

Type of examination requested

Documentation of identification of pregnancy status or breastfeeding, if relevant.

In relation to the pregnancy / breastfeeding question this was relevant in 20 (33%) of the 60 referrals reviewed. Three (5%) pregnancy consent forms were not scanned to the radiology system at the time of audit but were waiting to be scanned. The audit team viewed two of these original pregnancy consent forms and can confirm that they were signed appropriately.

Areas of non-compliance were found in relation to the following criteria:

Patient’s gender on referral – one site was non-compliant on 03/10 referral documents reviewed

Information about previous relevant examinations – two sites were non-compliant on 04/10 and 01/10 referral documents reviewed.

As can be seen from the above findings, all six sites were compliant with the criteria selected for audit from the HERCA data collection tool.

Audit

The audit team found evidence that all sites were engaged in ongoing audit to develop and enhance the justification process. Examples of these audits included the following:

Review of whole body positron emission tomography/CT protocol,

Audit of fast brain protocol,

CT brain in the emergency department,

Image quality, and

Diagnostic reference levels

One site had developed an Annual Radiology Quality Report 2016 which detailed all ongoing audits relating to radiology and incorporated quality improvement plans. Another site had presented their audit findings in poster format at a hospital wide symposium. Several sites had included results of audit in local teaching sessions.

Training/Education

Training and education was ongoing at all six sites to further develop the professional skills and knowledge of staff in addressing the justification process in diagnostic radiology. Three sites provided written evidence and staff sign-in sheets/file records to verify attendance at various continuous education and training events. These included internal and external study days, lectures, lunchtime presentations etc. Recommendations were issued to the remaining three sites to ensure that education/training delivered is recorded and planned in a systematic way.


Good Practice Initiatives

In the opinion of the audit team, and in consultation with the context expert, the following good practice initiatives involving aspects of the justification process were noted:

The development of specific checklists/processes around CT.

The development of a pocket sized prompt card to use when ordering images.

The use of a quality assurance radiology tool to assist radiographers whilst performing peer review.

The development of the diagnostic user manual for consultants.

The system to capture and record why some referrals were declined/rejected.

The development of an annual radiology quality report on local audit.

The development of a competency checklist attached to the induction programmes for new staff.

5. CONCLUSION

Based on the evidence reviewed, the audit team can provide reasonable assurance that that all six sites had governance structures and PPPGs in place to support the justification process, and were in line with the requirements of SI 478 and the MERU manual.

The audit team noted that in all sites plain film X rays were routinely justified by radiographers, however no documentary evidence was found that this practice was formally delegated in writing from the practitioner in charge (radiologist) to the radiographers.

The audit team can provide reasonable assurance that five sites had appropriate documentation in place to support the justification principle as detailed in section 5 of the MERU manual. Limited assurance was provided to one site in this regard.

All sites were engaged in audit and training/education around aspects of justification.

Recommendations made in this report, listed hereunder, identify actions that MERU must implement in order to further strengthen the current justification process in diagnostic radiology.

6. RECOMMENDATIONS

Recommendations made in this report identify actions that the senior most accountable person for MERU must implement.

1. Section 5 of the RP Manual must be amended to include further guidance for all facilities using medical ionising radiation regarding a local justification protocol. Based on the findings from this audit, the protocol must also include the following:

a. Guidance to the practitioner in charge regarding the formal delegation of authority to justify procedures and that this practice must be formally documented in the local procedure.

b. Guidance regarding the requirements in relation to comforters and carers and that this must be reflected in the local comforters and carers policy.

Once amended, section 5 the RP Manual should be re-issued and communicated formally to all facilities using medical ionising radiation.


Acknowledgements:

The audit team wish to acknowledge the co-operation and goodwill afforded to them by the management and staff in MERU and all locations audited.

Lead Auditor Ms. Catherine Timoney

Signature

Date 17 July 2017

Assistant National Director, Healthcare Audit, QAVD

Ms Cora McCaughan

Signature

Date 17 July 2017


APPENDIX A: SITE SPECIFIC RECOMMENDATIONS

The senior most accountable person at each site must ensure that:

Name of Site Recommendations

The Hermitage Medical Centre

1. The number of referral requests that are changed as a result of the justification process is captured and documented.

Cork University Hospital

1. The appropriate section(s) of the Radiation Safety Manual CUH are changed to include the following:

Reference to the statutory requirements of SI 478/303/459.

The role and responsibilities of the PIC in relation to the justification process.

2. The local consent policy is updated.

3. An individual policy on comforters/carers is developed.

4. All education/training delivered is recorded to include details of the education/training event title, the scheduled date/time of the training and the names of the staff members in attendance.

Our Lady’s Hospital Navan

1. The development of a policy on the justification process.

2. The development of a policy on comforters and carers.

3. All education/training is planned and delivered in a systematic way

University Hospital Kerry

1. The appropriate section(s) of the local rules are amended to include the following:

Reference to the statutory requirements of SI 478/303/459.

The role and responsibilities of the PIC in relation to the justification process.

2. A policy on the justification process is developed.

The Galway Clinic

1. The appropriate section(s) of the local rules are amended to include:

The role and responsibilities of the PIC, including their role in relation to the justification process.

Section 6.6 is reviewed in order to ensure full clarity of the statement therein and to remove the current contradictory inferences found.

2. Paragraph three of the policy entitled ‘Best Practice When Taking X rays’ is amended to incorporate the changes made to Section 6.6 of the local rules.

3. A policy on the justification process is developed.

4. A policy on comforters and carers is developed.

5. The use of the European Commission Protection 118 Referral guidelines for imaging (2000) to justify radiological examinations is discontinued and replaced with the iRefer guidelines.

6. Relevant documentation is added to the appropriate sections of the RP manual.

7. The number of referral requests that are changed as a result of the justification process are captured and documented.

The following recommendation while outside the scope of the audit objectives, was included following discussion with the context expert.

8. Section 5.1 of the local rules is revised to state the requirement to report patient incidents/near misses to MERU as outlined in Section 3 of the RP manual.


Mayo University Hospital

1. Section 4.5 of the local rules is reviewed, in order to ensure full clarity of the statement therein and to remove the current contradictory inferences found.

2. A policy on comforters and carers is developed.

3. The number of referral requests changed as a result of the justification process is captured and documented.

4. The local rules and relevant SOPs are amended to remove reference to the European Commission Protection 118 Referral guidelines for imaging (2000).

5. All education/training delivered is documented and the names of those attending recorded.

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