Report of the assessment of compliance with medical ... Report of the assessment of compliance with...

of 17

Health Information and Quality Authority

Report of the assessment of compliance with medical exposure to ionising radiation regulations Name of Medical Radiological Installation:

Sligo University Hospital

Undertaking Name: Health Service Executive

Address of Ionising Radiation Installation:

The Mall, Rathquarter, Sligo

Type of inspection: Announced

Date of inspection:

29 January 2020

Medical Radiological Installation Service ID:

OSV-0007373

Fieldwork ID: MON-0028255

of 17

About the medical radiological installation:

Sligo University Hospital (SUH) Radiology Department provides a comprehensive

multidisciplinary radiology service including multislide computed tomography (CT),

nuclear medicine, fluoroscopy/interventional, orthopaedic, and general x rays. SUH

provides regional services for neurology, ear nose and throat (ENT), rheumatology,

ophthalmology, dermatology, urology and orthodontics. It was the first hospital to

implement the National Integrated Medical Imaging System (NIMIS) Picture

Archiving Communication System (PACS) in June 2011. There are approximately

100,000 examinations performed by the Radiology department each year. This

includes non-ionising radiation modalities. Radiology services are provided to hospital

in-patients, out-patient clinics, GPs and other hospital referrals.

of 17

How we inspect

This inspection was carried out to assess compliance with the European Union (Basic

Safety Standards for Protection against Dangers Arising from Medical Exposure to

Ionising Radiation) Regulations 2018 and 2019. The regulations set the minimum

standards for the protection of service users exposed to ionising radiation for clinical

or research purposes. These regulations must be met by each undertaking carrying

out such practices. To prepare for this inspection, the inspector1 reviewed all

information about this medical radiological installation2. This includes any previous

inspection findings, information submitted by the undertaking, undertaking

representative or designated manager to HIQA3 and any unsolicited information since

the last inspection.

As part of our inspection, where possible, we:

talk with staff and management to find out how they plan, deliver and monitor

the services that are provided to service users

speak with service users4 to find out their experience of the service

observe practice to see if it reflects what people tell us

review documents to see if appropriate records are kept and that they reflect

practice and what people tell us.

About the inspection report

In order to summarise our inspection findings and to describe how well a service is

complying with regulations, we group and report on the regulations under two

dimensions:

1. Governance and management arrangements for medical exposures:

1 Inspector refers to an Authorised Person appointed by HIQA under Regulation 24 of S.I. No. 256 of 2018 for

the purpose of ensuring compliance with the regulations. 2 A medical radiological installation means a facility where medical radiological procedures are performed. 3 HIQA refers to the Health Information and Quality Authority as defined in Section 2 of S.I. No. 256 of 2018. 4 Service users include patients, asymptomatic individuals, carers and comforters and volunteers in medical or

biomedical research.

of 17

This section describes HIQA’s findings on compliance with regulations relating to the

oversight and management of the medical radiological installation and how effective

it is in ensuring the quality and safe conduct of medical exposures. It outlines how

the undertaking ensures that people who work in the medical radiological installation

have appropriate education and training and carry out medical exposures safely and

whether there are appropriate systems and processes in place to underpin the safe

delivery and oversight of the service.

2. Safe delivery of medical exposures:

This section describes the technical arrangements in place to ensure that medical

exposures to ionising radiation are carried out safely. It examines how the

undertaking provides the systems and processes so service users only undergo

medical exposures to ionising radiation where the potential benefits outweigh any

potential risks and such exposures are kept as low as reasonably possible in order to

meet the objectives of the medical exposure. It includes information about the care

and supports available to service users and the maintenance of equipment used

when performing medical radiological procedures.

A full list of all regulations and the dimension they are reported under can be seen in

Appendix 1.

This inspection was carried out during the following times:

Date Times of

Inspection

Inspector Role

Wednesday 29 January 2020

09:00hrs to 17:00hrs

Lee O'Hora Lead

Wednesday 29 January 2020

09:00hrs to 17:00hrs

Agnella Craig Support

of 17

Governance and management arrangements for medical exposures

Inspectors found effective governance, leadership and management arrangements with a clear allocation of responsibility for the protection of service users undergoing medical exposures at Sligo University Hospital (SUH). Overall responsibility for the radiation protection of service users was held by the HSE. Within SUH, the radiography services manager and associate clinical director reported directly to the general manager. A radiation safety committee was incorporated into the governance system and reported into a quality and safety executive committee which reported directly to the executive management team and the general manager. Following document review and communication with management, practitioners and other staff, inspectors were satisfied that systems were in place to ensure the appropriate communication of all radiation safety issues effectively within SUH.

While good management and governance structures were found to be in place, there were also areas for improvement identified during the inspection. Clarity on the appropriate escalation and communication pathways via the National Radiation Protection Office (NRPO) in the HSE would improve SUH's ability to effectively communicate all radiation safety issues with the undertaking. Inspectors also highlighted an opportunity for senior management to strengthen regulatory oversight of DEXA scanning services delivered by SUH.

Inspectors reviewed documentation and spoke with senior management regarding medical physics expert (MPE) involvement in the safe delivery of medical exposures. Inspectors felt that the necessary regulatory requirements in relation to responsibilities, advice and contributions where satisfied. However, the involvement of the medical physics expert could be improved to reflect the potential radiological risk associated with interventional radiology, nuclear medicine, computed tomography and paediatric imaging. This was a point acknowledged by senior management throughout the inspection.

Overall, inspectors were satisfied that SUH provided clear structures, processes, guidance and support to ensure the safe referral and conduct of medical radiological procedures.

Regulation 4: Referrers

Inspectors were satisfied that referrals are only accepted from registered medical practitioners and registered nurses as recognised under Regulation 4. Referrer rights were only assigned to appropriately qualified staff via the Radiology Information

of 17

System (RIS). All scanned paper referrals seen by inspectors had evidence of professional registration. Inspectors observed information displayed throughout the department informing practitioners of specific scope of practise for individual nurse referrers.

Judgment: Compliant

Regulation 5: Practitioners

Sligo University Hospital (SUH) radiology work flow documents clearly assign responsibility for specific aspects of clinical responsibility to radiographers and radiologists, as appropriate. SUH staff articulated comprehensive knowledge of these processes to inspectors throughout the course of the inspection.

Judgment: Compliant

Regulation 6: Undertaking

Documents reviewed by inspectors gave a clear allocation of responsibilities for the radiation protection of service users. Minutes and terms of reference of the site specific radiation safety committee were reviewed by inspectors. Evidence that senior management is represented on the radiation safety committee by the assistant general manager was seen by inspectors. Document review and discussion with senior management, practitioners and other staff satisfied inspectors that good structures were in place to ensure a clear allocation of responsibility for the radiation protection of service users within SUH.

Awareness of the role of the National Radiation Protection Office (NRPO) and escalation of radiation safety issues via the NRPO was highlighted on the day as an area that required improvement. Inspectors were given an assurance that a system enabling communication with the undertaking would be established and implemented. However, inspectors were assured of the governance structures within SUH to oversee radiation safety issues and SUH demonstrated an ability to escalate issues via the hospital group if required.

Judgment: Compliant

Regulation 10: Responsibilities

Documentation reviewed by inspectors gave satisfactory assurances that all medical

of 17

exposures took place under the clinical responsibility of a practitioner. Roles and responsibilities of practitioners were well understood and articulated to inspectors by staff in the clinical area throughout the course of inspection.

Document review, senior staff engagement and evidence seen in the clinical area satisfied inspectors that SUH had systems and processes in place to ensure the appropriate involvement of the relevant staff in the justification and optimisation of medical procedures.

Inspectors noted that SUH operated two dexa scanners, documentation reviewed stated that these were under the regulatory guidance of SUH and the general manager. Records relating to the delegation of the practical aspects of the medical radiological procedures for the provision of dexa scanning were not evident on the day of inspection. It was acknowledged to inspectors that this was an area for improvement to ensure full governance oversight of regulatory compliance.

Judgment: Substantially Compliant

Regulation 19: Recognition of medical physics experts

Inspectors were satisfied that medical physics experts had appropriate professional registration. Inspectors were informed that a formal arrangement with a larger medical physics department in the hospital group supplied full medical physics expert cover. Inspectors were satisfied that the existing arrangement ensured continuity of expertise.

Judgment: Compliant

Regulation 20: Responsibilities of medical physics experts

Documents reviewed by inspectors clearly defined the responsibilities of the MPE in line with regulatory requirements. Inspectors reviewed records of acceptance testing and performance testing undertaken by the medical physics expert. Inspectors also reviewed evidence of medical physics contribution to DRL application and use, radiology equipment quality assurance, analysis of accidental or unintended exposures and staff training.

Judgment: Compliant

Regulation 21: Involvement of medical physics experts in medical radiological practices

of 17

Inspectors reviewed documentation and noted that the medical physics expert was also acting as the radiation protection adviser (RPA) for SUH. Inspectors found that the involvement of the MPE could be improved to reflect the services in SUH, for example nuclear medicine, interventional radiology, paediatric imaging and computed tomography. Senior management acknowledged the possible shortcomings with the existing arrangement and inspectors were informed that the issue has been formally reported to the radiation safety committee. Although the overall input of the MPE did not present a current patient safety risk, management at SUH should review the level of involvement of the MPE in nuclear medicine, interventional radiology, paediatric imaging and computed tomography and implement any changes required considering the potential risk associated with higher dose procedures.


Safe Delivery of Medical Exposures

Inspectors found that radiation protection processes implemented by SUH ensured the safe delivery of medical exposures. No significant risks to the safety, health or welfare of service users were identified during inspection.

Evidence of comprehensive protocols and availability of referral guidelines provided assurances that SUH delivered medical exposures appropriately and consistently. Inspectors saw evidence that SUH employed measures to inquire and record the pregnancy status of service users, where appropriate, in a manner satisfying all regulatory requirements. Inspectors were also satisfied that SUH took reasonable measures to minimise the probability of accidental or unintended exposures of individuals subject to medical exposures.

Inspectors were satisfied that SUH has processes in place to ensure that all medical procedure referrals are accompanied by the relevant information and justified in advance by a practitioner. However, the recording of practitioner justification was not evidenced consistently and this was identified as an area for potential improvement to ensure regulatory compliance.

Inspectors observed records and evidence that SUH established and reviewed DRLs annually. In a small number of instances where SUH DRLs exceeded national DRLs, a record of the investigation and corrective actions was not available. This also was seen as an area for consideration to ensure regulatory compliance in the future.

Furthermore while evidence of radiology departmental radiation audits was seen by inspectors, inspectors were informed that departmental audits have been adversely affected by staffing related issues. Inspectors were informed that SUH had a clinical audit support team in place at a hospital level and that this team was led by an audit coordinator who sat on the quality and safety executive committee. A more comprehensive, multidisciplinary approach by SUH to support and promote the audit

of 17

process may improve and formalise the radiology department's ability to audit aspects of service delivery essential for the safe delivery of medical exposures to service users.

Regulation 8: Justification of medical exposures

Inspectors were satisfied that all individual medical exposures were justified in advance but found that a record of this was not available on all referrals reviewed. Inspectors observed that a digital vetting system had the ability to record individual justification, and was evidenced in some circumstances but this was not routinely used for all referrals.

All referrals reviewed by inspectors on the day satisfied regulatory requirements in relation to information supplied to the practitioner. Inspectors were satisfied that previous diagnostic information was readily available to both referrers and practitioner via the national integrated medical imaging system. The documented responsibilities of both referrer and practitioner to seek this information was also well evidenced on the day of inspection.

Information relating to the benefits and risks associated with medical exposures was observed throughout the department in handout and poster form. Inspectors spoke to clinical staff who demonstrated confidence in their ability to effectively communicate these issues with patients.


Regulation 11: Diagnostic reference levels

Inspectors were satisfied that DRLs were reviewed and used at SUH. DRL protocols reviewed by inspectors clearly assign responsibility to individuals for annual DRL review and dissemination. Inspectors observed DRL data displayed throughout the department and available electronically and this was demonstrated by staff in the clinical area. Evidence of staff training lectures in DRLs was also seen by inspectors.

Records seen by inspectors indicated that some DRLs were above national DRLs. Inspectors were satisfied that informal investigations were carried out which determined that no corrective action was needed; however, records of these investigations were not available on the day. In order to fulfil regulatory requirements, undertakings must maintain records of DRL reviews and any corrective actions necessary.


of 17

Regulation 13: Procedures

Written protocols for every standard medical radiological procedure were seen by inspectors. Staff in the clinical area demonstrated the ability to access these protocols to inspectors.

Referral guidelines were readily available to referrers. Inspectors spoke to staff who demonstrated good knowledge of the availability and use of these guidelines.

Inspectors observed and were informed that information relating to patient exposure did not form part of the medical radiological report.

Inspectors saw evidence of a radiation safety focused audit undertaken by the radiology department. Audits undertaken within the department were communicated using radiology and radiography QA meetings, which were held every six weeks to two months, as well as via RPO radiation safety training events; records of which were seen by inspectors for 2019. During the course of inspection, inspectors were informed that pregnancy compliance audits and patient ID check audits were not carried out in 2019 due to staffing shortages.


Regulation 14: Equipment

Inspectors were satisfied that all medical radiological equipment in use was kept under strict surveillance. Inspectors reviewed quality assurance reports including performance and acceptance testing for a range of radiological equipment and saw evidence of radiographer run quality assurance programmes.

An up-to-date inventory of radiological equipment was supplied to inspectors.

Judgment: Compliant

Regulation 16: Special protection during pregnancy and breastfeeding

Inspectors reviewed SUH policy relating to the protection of service users during pregnancy and breast feeding. Inspectors were satisfied that this policy clearly defined the responsibilities of the persons involved. Clinical staff consistently articulated a good understanding of this policy to inspectors on the day. Evidence of appropriate records in line with policy and fulfilling all regulatory requirements was

of 17

seen by inspectors.

Public notices relating to special protection during pregnancy and breastfeeding were observed in patient waiting areas and throughout the department.

Judgment: Compliant

Regulation 17: Accidental and unintended exposures and significant events

On the day of inspection, inspectors were satisfied that SUH took reasonable measures to minimise the probability and magnitude of accidental or unintended exposures of individuals subject to medical exposures.

Inspectors saw evidence that all radiation incidents are dealt with via an electronic, hospital wide data management system. This system ensures oversight at a departmental and hospital level by generating individual annual reports for appropriate senior staff. Staff demonstrated a good understanding of their responsibilities in reporting and mitigating risk when asked by inspectors. Inspectors saw evidence of staff training in radiation incident categorisation and reporting pathways and were informed that radiographer and radiologist QA meetings also facilitated the appropriate dissemination of learning from incidents reported.

Judgment: Compliant

of 17

Appendix 1 – Summary table of regulations considered in this report This inspection was carried out to assess compliance with the European Union (Basic Safety Standards for Protection against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 and 2019. The regulations considered on this inspection were:

Regulation Title Judgment

Governance and management arrangements for medical exposures

Regulation 4: Referrers Compliant

Regulation 5: Practitioners Compliant

Regulation 6: Undertaking Compliant

Regulation 10: Responsibilities Substantially Compliant

Regulation 19: Recognition of medical physics experts Compliant

Regulation 20: Responsibilities of medical physics experts Compliant


Substantially Compliant

Safe Delivery of Medical Exposures

Regulation 8: Justification of medical exposures Substantially Compliant

Regulation 11: Diagnostic reference levels Substantially Compliant

Regulation 13: Procedures Substantially Compliant

Regulation 14: Equipment Compliant

Regulation 16: Special protection during pregnancy and breastfeeding

Compliant

Regulation 17: Accidental and unintended exposures and significant events

Compliant

of 17

Compliance Plan for Sligo University Hospital OSV-0007373 Inspection ID: MON-0028255

Date of inspection: 29/01/2020 Introduction and instruction This document sets out the regulations where it has been assessed that the undertaking is not compliant with the European Union (Basic Safety Standards for Protection against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 and 2019. This document is divided into two sections: Section 1 is the compliance plan. It outlines which regulations the undertaking must take action on to comply. In this section the undertaking must consider the overall regulation when responding and not just the individual non compliances as listed in section 2. Section 2 is the list of all regulations where it has been assessed the undertaking is not compliant. Each regulation is risk assessed as to the impact of the non-compliance on the safety, health and welfare of service users. A finding of:

Substantially compliant - A judgment of substantially compliant means that the undertaking or other person has generally met the requirements of the regulation but some action is required to be fully compliant. This finding will have a risk rating of yellow which is low risk.

Not compliant - A judgment of not compliant means the undertaking or other person has not complied with a regulation and considerable action is required to come into compliance. Continued non-compliance — or where the non-compliance poses a significant risk to the safety, health and welfare of service users — will be risk rated red (high risk) and the inspector will identify the date by which the undertaking must comply. Where the non-compliance does not pose a risk to the safety, health and welfare of service users, it is risk rated orange (moderate risk) and the undertaking must take action within a reasonable timeframe to come into compliance.

of 17

Section 1 The undertaking is required to set out what action they have taken or intend to take to comply with the regulation in order to bring the medical radiological installation back into compliance. The plan should be SMART in nature. Specific to that regulation, Measurable so that they can monitor progress, Achievable and Realistic, and Time bound. The response must consider the details and risk rating of each regulation set out in section 2 when making the response. It is the undertaking’s responsibility to ensure they implement the actions within the timeframe. Compliance plan undertaking response:

Regulation Heading Judgment

Regulation 10: Responsibilities


Outline how you are going to come into compliance with Regulation 10: Responsibilities: Delegation of the practical aspects of the medical radiological procedures for the provision of DEXA scanning to be agreed and documented 01/05/2020



Outline how you are going to come into compliance with Regulation 21: Involvement of medical physics experts in medical radiological practices: Business case to be forwarded to SAOLTA University Health Care Group to seek additional Medical Physics Support to the service. To be submitted by 01/05/2020

Regulation 8: Justification of medical exposures


Outline how you are going to come into compliance with Regulation 8: Justification of medical exposures: Currently unable to record justification for general x-ray on NIMIS. Vetting module not

of 17

used for General X-ray. NIMIS contacted and seeking resolution. Matter to be discussed at the forthcoming Radiation Safety Committee meeting to discuss any interim measures that can be put in place 30/11/2020

Regulation 11: Diagnostic reference levels


Outline how you are going to come into compliance with Regulation 11: Diagnostic reference levels: DRL Protocol has been updated to include Record of Corrective Actions. Completed

Regulation 13: Procedures


Outline how you are going to come into compliance with Regulation 13: Procedures: Patient ID & Triple LMP audits for 2019 will be completed by end of Q1, 2020. Staffing Levels improved that will allow audits to be completed on a timely basis. Information relating to patient exposure doesn’t currently form part of the report. This is currently not possible on NIMIS. National NIMIS office aware and required to address same. 31/12/2020

of 17

Section 2: Regulations to be complied with The undertaking and designated manager must consider the details and risk rating of the following regulations when completing the compliance plan in section 1. Where a regulation has been risk rated red (high risk) the inspector has set out the date by which the undertaking and designated manager must comply. Where a regulation has been risk rated yellow (low risk) or orange (moderate risk) the undertaking must include a date (DD Month YY) of when they will be compliant. The undertaking has failed to comply with the following regulation(s).

Regulation Regulatory requirement

Judgment Risk rating

Date to be complied with

Regulation 8(8) An undertaking shall ensure that all individual medical exposures carried out on its behalf are justified in advance, taking into account the specific objectives of the exposure and the characteristics of the individual involved.


Yellow

30/11/2020

Regulation 8(15) An undertaking shall retain records evidencing compliance with this Regulation for a period of five years from the date of the medical exposure, and shall provide such records to the Authority on request.


Yellow

30/11/2020

Regulation 10(5) An undertaking shall retain a record of each delegation pursuant to paragraph (4) for a

Not Compliant

01/05/2020

of 17

period of five years from the date of the delegation, and shall provide such records to the Authority on request.

Regulation 11(7) An undertaking shall retain a record of reviews and corrective actions carried out under paragraph (6) for a period of five years from the date of the review, and shall provide such records to the Authority on request.

Not Compliant

31/03/2020

Regulation 13(2) An undertaking shall ensure that information relating to patient exposure forms part of the report of the medical radiological procedure.

Not Compliant

31/12/2020

Regulation 21(1) An undertaking shall ensure that, in medical radiological practices, a medical physics expert is appropriately involved, the level of involvement being commensurate with the radiological risk posed by the practice.


Yellow

31/12/2020

Report of the assessment of compliance with medical ... Report of the assessment of compliance with...

Documents

Transcript of Report of the assessment of compliance with medical ... Report of the assessment of compliance with...