former conwy and denbighshire nhs trust review of … · review of progress against ionising...

31
Former Conwy and Denbighshire NHS Trust Review of Progress against Ionising Radiation (Medical Exposure) Regulations 2000 and the Ionising Radiation (Medical Exposure) Amendment Regulations 2006 (IR(ME)R) October 2007

Upload: lyhuong

Post on 05-Jun-2018

217 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

FormerConwy and Denbighshire NHS Trust

Review of Progress against Ionising Radiation (Medical Exposure) Regulations 2000 and the Ionising Radiation (Medical Exposure) Amendment Regulations 2006 (IR(ME)R)

October 2007

Page 2: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and
Page 3: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

Contents

1. Introduction and Context 1

2. Previous Audits and Inspections 3

3. Nuclear Medicine Department

i) Department Information

ii) Quality Of Patient Care

iii) Supporting Elements

iv) Summary Of Recommendation For Department

v) Summary Of Note Worthy Practice For Department

56

13

1415

4. Diagnostic Imaging Department

i) Department Information

ii) Quality Of Patient Care

iii) Supporting Elements

iv) Summary Of Recommendation For Department

v) Summary Of Note Worthy Practice For Department

17182323

25

5. General Themes 27

Page 4: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and
Page 5: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

1

1. INTRODUCTION AND CONTEXT

On 30th and 31st October 2007 an assessment of the Nuclear Medicine and Diagnostic

Imaging Departments at Ysbyty Glan Clwyd Hospital was undertaken by Healthcare

Inspectorate Wales (HIW), the Health Protection Agency (HPA) and the Health and Safety

Executive (HSE). The visit was proactive and the department was required to complete a

self-assessment prior to the visit and the information provided therein was used to inform

discussions with key members of the departments.

The assessment involved a review of practice, including the administration of radioactive

medicinal products and standard operating procedures (SOPs). SOPs were also

considered in relation to the IR(ME) Regulations 2000. Practice in the external

radiopharmacy was excluded from the assessment, however, systems of work and written

procedures regarding the receipt of products from the radiopharmacy by the nuclear

medicine department were considered.

The Trust will be required to develop an action plan in response to the recommendations

in this report.

Page 6: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

2

Page 7: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

3

2. PREVIOUS AUDITS AND INSPECTIONS

Nuclear Medicine

A previous pro-active IR(ME)R inspection of the department was undertaken on the 18th

November 2003, which was carried out by the IR(ME)R Inspectorate at the Department of

Health on behalf of the National Assembly for Wales. Recommendations made as a

consequence of the inspection were documented on the day of the visit and have since

been acted upon, however, no formal written report was forwarded to the Trust.

In addition, an Environmental Agency review and inspection of radioactive waste and work

environment was undertaken on the 17th July 2007. Although at the time of our visit no

report had been received by the Trust we were told that positive verbal feedback had been

given by the review team.

Diagnostic Imaging

A previous pro-active IR(ME)R inspection of the department was undertaken in 2001 by

the IR(ME)R Inspectorate at the Department of Health on behalf of the National Assembly

for Wales. Recommendations made as a consequence of the inspection were documented

on the day of the inspection and have since been acted upon, however, no formal written

report was forwarded to the Trust.

A Health and Safety Executive (HSE) inspection was undertaken in 2001 to ensure

compliance with IRR99. A further HSE follow-up inspection undertaken in 2006 confirmed

that recommendations had been acted upon.

Page 8: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

4

Page 9: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

5

3. NUCLEAR MEDICINE DEPARTMENT

i) Departmental Information

Activity

During 2006-07, 1187 diagnostic nuclear medicine procedures were carried out by the

nuclear medicine department. No therapeutic nuclear medicine interventions are

administered at the department.

Equipment and Facilities

A detailed equipment inventory and local procedures for equipment testing are in place.

These procedures are noteworthy.

Quality of Environment

The department was clean, comfortable, generally well designed and maintained and was

self-contained. There are sufficient changing rooms and patient gowns for nuclear

medicine patients, although separate waiting areas for in-patients and out-patients are not

available.

Staff Providing Nuclear Medicine Services

There are 3, whole time equivalent (wte) consultants who are Administration of

Radioactive Substances Advisory Committee (ARSAC) certificate holders, who work within

the department, however, only some were significantly involved with nuclear medicine.

There are 9 Specialist Registrars working in radiology on rotation throughout North Wales,

with a maximum of 3 in Conwy and Denbighshire NHS Trust at any one time. There are

4.8 wte radiographers with a post graduate qualification in nuclear medicine but only two

work in the exposure room at any one time. 1.1 wte Medical Technical Officers, 2 wte

physicists, 0.6 wte Radiopharmacists and 3 Radiation Protection Supervisors (RPS) staff

are working on site. Also the Trust has 1 wte nuclear medicine radiography student and 1

Page 10: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

6

medical physics student. There are 10 ARSAC certificate holders within the Trust, of

which 3 are working with the radiology department.

While evidence was provided to confirm that Computered Tomography (CT) training is

undertaken by the Nuclear Medicine radiographers such training was not formally

recorded. We identified that training records are not always completed at the time of

training, although training records are available. However medical staff training records

are very detailed and clearly laid out, and we consider this to be noteworthy practice.

We recommend that:

• All training, including CT, is formally recorded in training records; [See IR(ME) Regulation 4(4); 11 (1); 11(4)].

ii) Quality of Patient Care

Access to Nuclear Medicine services

The written procedures in place for access to Nuclear Medicine services are reviewed

every 3 years in line with the Trust’s review policy. However, we consider that they require

review for consistency and to ensure appropriate cross-referencing. There is also a need

to ensure that the use of terminology is correct and consistent (e.g. 'prior' and 'delegated'

authorisation) and also that consideration needs to be given as to whether every one of

the existing procedures accurately reflects practice ('if it doesn't happen in practice, take it

out').

The engagement of senior management within the Trust in the review and development of

written procedures is essential. It is important that employer responsibility is clearly

recognised and understood at Trust Board level and that consideration is given to the

process of establishing and reviewing them to ensure the involvement of the Clinical

Director in the ratification of procedures. Further, systems should be put in place to

ensure that all revisions and amendments to written procedures are clearly communicated

to staff.

Page 11: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

7

We recommend that:

• a review of written procedures is undertaken to ensure consistency, and appropriate

cross-referencing ;[See IR(ME) Regulation 4(2); Healthcare Standard 19].

• senior management are engaged in the review and development of all written

procedures; [See IR(ME) Regulation 4(2); Healthcare Standard 19].

• all revisions and amendments to written procedures are clearly communicated to staff;

[See IR(ME) Regulation 4(2); Healthcare Standard 19].

Referral Criteria

The Trust uses the Royal College of Radiologists referral guidelines.

We consider that a review of the entitlement procedure is required to ensure clarity and

accuracy. The Trust should issue a letter of entitlement to new (medical) referrers setting

out the scope of the services they provide, entitlement criteria and details of the referral

process.

The Accident and Emergency (A/E) referral form should be revised so that its layout and

format are similar to that already used for other referrals into the Diagnostic Imaging and

Nuclear Medicine Department, which is very clear and easy to use.

We recommend that:

• a review of entitlement procedures is undertaken; [IR(ME)R Schedule 1 (b)].

• the Trust issues a letter of entitlement to new (medical) referrers setting out the scope

of the services they provide, entitlement criteria and details of the referral process.

• Radiology- A&E need to complete the review of their referral form, adopting a similar

layout to those currently used in Diagnostic Imaging and Nuclear Medicine.

Page 12: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

8

Supply of sufficient relevant medical data

Requests for procedures are received via radiology request forms, paper or electronic, or

by referral letters, which are sent direct to the Consultant Radiologist. The nuclear

medicine practitioner or nuclear medicine authorising officer reviews all requests.

However, there is currently a lack of clarity in relation to the role of tertiary referrers and

this needs to be addressed within the policies and procedures.

All paper request forms are reviewed for completeness on receipt and any incomplete

requests are returned to the referrer with a letter explaining what additional information is

required. A ‘return log’ is completed by the radiographer who records the date the request

form was returned and to whom. This recognised as noteworthy practice.

We recommend that:

• The role of tertiary referrers needs to be clarifies within the written policies and

procedures.

The Justification Process

The department has a written procedure to identify those individuals entitled to act as

practitioners. However this procedure needs some clarification and updating in line with

IR(ME)R Amendment Regulations 2006 and the Medicine Administration of Radioactive

Substances ( MARS) Amendment Regulations 2006.

Written procedures identify the range of examinations that each practitioner or group of

practitioners can justify in accordance with each practitioners Administration of Radioactive

Substances Advisory Committee (ARSAC) licence. The written procedure does not entitle

persons other than consultant radiologists to justify examinations.

The written procedure does not include reference to locum or agency staff as this type of

staff are not employed within the department. Should this situation change within the

department, the procedure would need to address it.

Page 13: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

9

Justification

The Department has justification guidelines in place. However the role of the practitioner

is not made clear within the written procedures.

The practitioner directly justifies and authorises an examination, and then he/she will sign

the practitioner box. However if the examination is authorised by an operator, the

justification guidelines state the authorising operator is to sign in the box labelled ‘operator

initiating radiation exposure’ and insert the practitioners initials in the practitioner box.

We recommend that:

• the justification guidelines need to be more explicit in identifying who the practitioner is.

Special Attention

There is a written procedure in place that highlights that special attention is to be paid to

the justification where there is no direct health benefit to the individual, the urgency of the

exposure where pregnancy cannot be excluded and where the patient is breastfeeding.

Practical Aspects

Written procedures are in place that set out the scope of practice associated with each

operator or group of operators. The categories of practice assigned to each are indicated

in the operator matrix. Individuals entitled to act as an operator are identified by name and

grade.

The written procedure does not include reference to locum or agency staff as these are not

employed within the department. Should this situation change within the department, the

procedure would need to address it.

Local rules for the nuclear medicine department are in place.

Page 14: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

10

Preparation of Radioactive Medicinal Products (RMPs)

Written protocols are in place that set out the arrangements for every type of standard

practice for each piece of equipment. There is a written procedure for the review and

amendment of these written protocols and policies and procedures are reviewed every 3

years in line with the Trust’s review policy. However, we identified a need to review written

procedures for consistency and to ensure appropriate cross-referencing.

There is a written procedure in place relating to the requirement that special attention be

paid to the optimisation of medico-legal exposures, medical exposures involving high

doses, females in whom pregnancy cannot be excluded and females who are breast

feeding. This procedure does not cover paediatric examinations as these are conducted in

accordance with the ARSAC guidelines.

There is a written procedure concerning the preparation of Radioactive Medicinal Products

(RMPs) and this clearly identifies individual roles and responsibilities, which is mirrored in

the radiopharmacy operator matrix to ensure consistency. Documentation regarding the

preparation of RMPs is maintained via stock receipts, copies of requests and batch sheets,

which are recorded and filed. For each item received a request form is signed for prior to

a RMP being prepared. Worksheets are also checked and signed before and after

preparation and are again signed to document the release of the product. The individuals

who can authorise request forms, worksheets and release documentation are set out in

the operator matrix.

RMPs are prepared as patient doses in radiopharmacy and delivered in a syringe that is

shielded by an individual lead carrier. Each syringe is labelled with details of the following:

radioisotopes, format of radioisotope, patient name and ID number, and date and time of

administration. When ready RMPs are delivered to Gamma Camera room and stored in a

locked fridge until administration. Also each lead carrier is similarly labelled but with

patient’s initials instead of the name and ID number.

Personnel dose rates are monitored continuously and surface contamination monitoring is

undertaken daily and records of the results are kept.

Page 15: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

11

We recommend that:

• a review of the written procedures is needed to check for consistency and cross-

referencing, where appropriate; [See IR(ME)R Reg 4(2); Healthcare Standard 19].

Pre-administration

Radioactive Medical Products are administered within the Radioisotope room. Details

surrounding emergency situations were not discussed on the day of the inspection.

Each RMP preparation is carried from Radiopharmacy to the place of administration in

lead shielded containers by appropriately trained portering staff, Medical Physics staff,

Nuclear Medicine radiographers or radiopharmacy staff.

A patient information sheet is sent out to patients prior to them attending their examination.

On attendance at the appointments, the radiographer provides the patients with a full

verbal description of the examination including any possible side-effects. Advice is given

to patients as to how to reduce radiation dose to particular organs e.g. bladder. Information

given to patients in an emergency situation was not discussed on the day of the

inspection.

Administration of the Radioactive Medical Product (RMP)

There is a written policy for the identification of patients, which clearly identifies who is

responsible for identifying the patient as the one requiring the treatment. The policy also

addresses situations where a person may not be able to identify themselves fully e.g.

young children, people with a mental impairment, unconscious or unknown patients.

There is a policy for the protection of women of child bearing age which identifies the age

range for females of whom an enquiry must be made in relation to whether there is a risk

of them being pregnant. The policy clearly identifies which person has the responsibility

for enquiring if a female patient is pregnant or breastfeeding. However, this policy does

not address situations whereby a person may not be able to respond to the enquiry e.g.

Page 16: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

12

mentally impaired or unconscious patients, nor does the policy respect the patient’s right to

dignity and confidentiality.

Patients’ informed consent is sought prior to diagnostic procedures and written information

is given to each patient or their representative as appropriate regarding the medical

exposure.

There is a policy in place regarding Diagnostic Reference Levels (DRLs). The DRLs are

based on ARSAC guidelines with a +/- 10% differential allowance and to support this a

procedure in place for exceeding DRLs for individuals. Administered activity is checked by

the superintendent Radiographer on a monthly basis to ensure that DRLs remain within

their limits.

There are policies in place concerning the clinical evaluation of all medical exposures,

assessment of patient dose and administered activity and a written procedure for the

recording of patient doses.

Appropriate materials are used to prevent the spread of contamination from the injection of

radioisotopes and radiopharmaceuticals. All doses are moved in clinical receivers on a

trolley. Staff are required to wash their hands after contact with any radioactive material or

patient. All areas are monitored for contamination at the end of each day. All staff that

have had contact with radioactive material are monitored for contamination after each

session.

We recommend that:

• the policy for the protection of women of child bearing age should be amended to take

account of situations whereby a person may not be able to respond to the enquiry.

Page 17: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

13

iii) Supporting Elements

IRMER Schedule 1 (e) requires written procedures for ensuring that quality assurance

programmes are undertaken, however there was no such procedure in place. The only

process for quality assurance was by an audit carried out prior to IR(ME)R and IRR99

inspections.

There is a written procedure concerning medical exposures made as part of research.

There is a policy and procedure concerning the internal/ external reporting of actual or

suspected incidents occurring within the Nuclear Medicine Department, regardless of type.

A specific procedure is also in place concerning individuals being exposed to a greater

than intended dose of ionising radiation. This procedure is consistent with the Trust

reporting policy. There is also a written procedure to ensure the probability and magnitude

of accidental or unintended doses to patients from radiological practices are reduced as far

as reasonably practicable. Untoward incidents are reported using the Trust’s IR1 book.

All incidents involving radiation are also formally investigated and reported to the Radiation

Protection Committee.

Some clinical audit has been undertaken and within the last year audits of Paediatric Dose

and Injection Competency have been carried out. The last management/Radio Pharmacy

Audit (RPA) of radiation protection identified difficulties in relation to formal training which

has since been addressed. It also identified that Risk Assessments needed to be updated,

which is still to be actioned.

Page 18: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

14

iv) Summary of Recommendations for Nuclear Medicine

We recommend that:

• procedures are written to ensure Quality Assurance programmes are followed; [IRMER

Schedule 1 (e)];

• All training, including CT, is formally recorded in training records; [See IR(ME)

Regulations 4(4);11(1);11(4)];

• a review of written procedures is undertaken to ensure consistency, and appropriate

cross-referencing; [See IR(ME) Regulation 4(2); Healthcare Standard 19];

• senior management are engaged in the review and development of all written

procedures; [See IR(ME) Regulation 4(2); Healthcare Standard 19];

• all revisions and amendments to written procedures are clearly communicated to staff;

[See IR(ME) Regulation 4(2); Healthcare Standard 19];

• a review of entitlement procedures is undertaken [IR(ME)R Schedule 1 (b)];

• the Trust issues a letter of entitlement to new (medical) referrers setting out the scope

of the services they provide, entitlement criteria and details of the referral process;

• radiology- A&E need to complete the review of their referral form, adopting a similar

layout to those currently used in Diagnostic Imaging and Nuclear Medicine;

• the role of tertiary referrers needs to be clarified within the written policies and

procedures;

• the justification guidelines need to be more explicit in identifying who the practitioner is;

• the policy for the protection of women of child bearing age should be amended to take

account of situations whereby a person may not be able to respond to the enquiry;

Page 19: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

15

• written procedures for ensuring Quality Assurance programmes are followed [IRMER

Schedule 1 (e)];

• risk assessment should be updated on a regular basis.

v) Summary Of Note Worthy Practice For Nuclear Medicine

§ Medical staff training records which are very detailed and clearly laid out.

§ The Imaging Department’s referral form, which is clear and easy to use.

§ A ‘returns log’ that is completed by the radiographer to record the date and who any

incomplete referrals are sent to.

Page 20: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

16

Page 21: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

17

4. DIAGNOSTIC IMAGING DEPARTMENT

i) Department Information

Activity

During 2006-07 approximately 76,000 radiography procedures were carried out.

Fluoroscopy, Computed Tomography (CT) and Magnetic Resonance (MR) scanning,

interventional radiology, mammography, ultra sound scanning and dental procedures are

also carried out within the department.

Physicians provide cardiology interventions with radiographer support from the imaging

department. Physicians are part of a separate management system and structure within

the Trust compared to the main imaging department.

Equipment and facilities

A detailed equipment inventory and local procedures for equipment testing are in place.

The equipment inventory is very clear and comprehensive, which is noteworthy practice.

Quality of environment

The main imaging department is located in the old part of the hospital site that has a

particular problem with asbestos, which prohibits the creation of larger waiting areas.

Although there are separate waiting areas for in and out patients, there is an inadequate

supply of patient gowns available, which has been identified as an ongoing problem.

Patients have access to hand washing facilities following an intervention but no showering

facilities are available.

We recommend that:

• a review into the availability of patient gowns is undertaken to ensure adequate

numbers are available.

Page 22: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

18

Staff providing Diagnostic Imaging and interventional services

There are 7.8 whole time equivalent (wte) Consultant Radiologists that work within the

department. These include 2 Consultants who specialise in Mammography and 2 who

carry out interventional work, although all consultants participate in CT and MR scans.

There are 53.8 wte Radiographers and 5 Radiation Protection Supervisors (RPS). The

department also takes 3-4 students per year on rotation from the University of Wales,

Bangor, who rotate through all imaging areas.

The department has no long-term vacancies i.e. over 3 months.

All staff have appropriate skills and qualifications and receive the necessary training, which

is recorded within well kept staff training records.

All staff undertake a mandatory 1 day induction programme, with the exception of

consultant medical staff for whom no formal induction programme is in place. Junior

Doctors within which radiology has a 15-minute presentation slot, in addition they all

receive radiology guidelines and are directed to the website for additional details.

We recommend that:

• formal arrangements for induction for the consultant medical staff need to be

considered.

ii) Quality of Patient Care

Access to Diagnostic Imaging and interventional services

There are written procedures in place for access to Diagnostic Imaging and interventional

services which are reviewed every 3 years in line with the Trusts review policy. However

we consider they should be reviewed for consistency and to ensure appropriate cross-

referencing.

Page 23: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

19

The engagement of senior management in the review and development of written

procedures is essential. It is important that employer responsibility is clearly recognised

and understood at Trust Board level and that consideration is given to the process of

establishing and reviewing them to ensure the involvement of the Clinical Director in the

ratification of procedures. Further, systems should be put in place to ensure that all

revisions and amendments to written procedures are clearly communicated to staff.

Definitions of Entitlement within the policies and procedures need to be reviewed and

brought up to date. Staff were not aware the IR(ME)R Amendment Regulations which

were implemented in November 2006.

We recommend that:

• a review of all written procedures is undertaken to check for consistency and cross-

referencing, where appropriate; [IRMER Reg 4(2); Healthcare Standard 19];

• senior management are engaged in the revision and amendments of all written

procedures; [IRMER Reg 4(2); Healthcare Standard 19];

• the trust need to ensure that staff are made aware of the IR(ME) Amendment

Regulations; implemented in November 2006.

Referral criteria

The Trust uses the Royal College of Radiologists referral guidelines. While version 6 of

the guidelines have been adopted by the Trust only version 5 was available on the Trust’s

website. This has resulted in two different versions of referral criteria being used and the

situation needs to be rectified.

The Trust should issue a letter of entitlement to new (medical) referrers setting out the

scope of the services they provide, entitlement criteria and details of the referral process.

We consider that a review of the entitlement procedure is required to ensure clarity and

accuracy. Open evenings for referrers are held by the Diagnostic Imaging Department to

explain the new referral form this is seen as good practice.

Page 24: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

20

The role of tertiary referrers is confusing. It is unclear if whether they are entitled to refer

in the same way as other medical referrers e.g. using the appropriate referral form.

The A&E referral form should be revised so that its layout and format are similar to that

already used for other referrals into the Diagnostic Imaging and Nuclear Medicine

Department, which is very clear and easy to use.

We recommend that:

• a review of entitlement procedures is undertaken; [IRMER Schedule 1(b)];

• the Trust issues a letter of entitlement to new (medical) referrers setting out the scope

of the services they provide, entitlement criteria and details of the referral process;

• the role of tertiary referrers focusing on entitlement needs to be clarified;

• the A&E referral form should be reviewed adopting a similar layout to those currently

used in Diagnostic Imaging and Nuclear Medicine.

Supply of sufficient relevant medical data

Requests for procedures are received via request forms, paper or electronic or referral

letters. All electronic requests are controlled by the ‘Trust Order Comms’ system.

All forms are reviewed for completeness on receipt and any incomplete requests are

returned to the referrer with a letter explaining what information is required. A ‘return log’

is completed by the radiographer who records the date the request form was returned and

to whom. This is noteworthy practice.

Justification Process

The department has a written procedure to identify those individuals entitled to act as

practitioners. The written procedure identifies the individual by name and professional

grade and entitles consultant radiologists and appropriately trained radiographers to act as

a practitioner. Written procedures identify the range of examinations that each practitioner

Page 25: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

21

or group of practitioners can justify dependent upon each practitioners training and

qualification. Dates when staff obtained a qualification need incorporating into

examination specific written procedures to ensure there is clarity on the range of

examination that can be justified by individual practitioners. Clarification is also required in

relation to the role of radiologists / Specialist Registrars (SpRs) in interventional work.

We recommend that:

• all written procedures are revised to ensure the appropriate use of terminology,

especially the words ‘justification’ and ‘authorisation’. Words such as ‘normally’ or

‘usually’ should be removed from these procedures; [IRMER Reg 6 Schedule 1(b)];

• the date of when staff obtained a qualification need incorporating into examination

specific written procedures;

• the role of radiologists / Specialist Registrars (SpRs) is provided in interventional work

is clarified.

Justification

The department has justification guidelines in place, although most medical exposures are

justified directly by practitioners (radiographers or radiologists) rather than those

individuals acting as operators. Both the practitioner and authoriser initial the request form

to ensure clear recording of justification and authorisation.

There is a written procedure in place stating that special attention should be given to the

justification of, medico-legal exposures, situations where there is no direct health benefit to

the individual and the urgency of the exposure where pregnancy cannot be excluded.

Practical Aspects

Written procedures are in place that set out the scope of practice associated with each

operator or group of operators. The categories of practice assigned to each are indicated

in the operator matrix. Individuals entitled to act as an operator are identified by name and

grade.

Page 26: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

22

Diagnostic Imaging or intervential Examination

There is a written procedure in place relating to the identification of patients. This

procedure clearly identifies which person has the responsibility for identification and

addresses situations where the person is unable to identify them self fully. It also covers

situations where more than one operator is directly involved in the medical exposure.

However, it does not set out the role of the assistant practitioners.

A clear procedure is in place in relation to making enquires of females of childbearing age

to establish whether there is a risk of them being pregnant. This identifies who is

responsible for making the enquiry and covers situations where an individual cannot

respond to the question, or where more than one operator is involved. It also highlights

issues of dignity and confidentiality.

Patients consent is actively sought prior to a procedure taking place and written

information and instructions are given to each patient or patient’s representative regarding

the medical exposure.

Diagnostic Reference Levels (DRL) are in place for each room and these are set locally.

There is also a written procedure in place for the review of DRLs if they are consistently

exceeded.

A written procedure for the clinical evaluation of all medical exposures and recording of

factors relevant to the patient dose is in place, which establishes how the making and

recording of clinical evaluations is the responsibility of the evaluating operator. In addition

there is also a written procedure for the assessment of patient doses.

We recommend that:

• Written procedures need to reflect the role of assistant practitioners; [IR(ME)R Reg

4(2) and Schedule 1].

Page 27: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

23

Research

Research is undertaken within the department and a written procedure is place concerning

medical exposures made as part of research.

The department has a good system in place for research trails and this is noteworthy.

Optimisation

Written protocols are in place for every type of standard practice for each piece of

equipment. However there is a need to review written procedures for consistency and to

ensure appropriate cross-referencing, as previously mentioned on page 15 of this report.

iii) Supporting Elements

A Medical Physics Expert establishes and reviews DRLs, quality assures radiographic

equipment and investigates all radiation incidents.

There is a written procedure concerning the internal and external reporting of actual or

suspected incidents.

Monthly multidisciplinary clinical audits are undertaken.

iv) Summary of Recommendations for Diagnostic Imaging

We recommend that:

• a review into the availability of patient gowns is undertaken and ensures adequate

number are available;

• formal induction arrangements for Consultant medical staff need to be considered;

• a review of all written procedures is undertaken to check for consistency and cross-

referencing, where appropriate; [IRMER Reg 4(2); Healthcare Standard 19];

Page 28: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

24

• senior management are engaged in the revision and amendments of all written

procedures; [IRMER Reg 4(2); Healthcare Standard 19];

• the trust need to ensure that staff are made aware of the IR(ME) Amendment

Regulations, implemented in November 2006;

• the Trust issues a letter of entitlement to new (medical) referrers setting out the scope

of the services they provide, entitlement criteria and details of the referral process;

• a review of entitlement procedures is undertaken; [IR(ME)R Schedule 1 (b)];

• the role of tertiary referrers, focusing on entitlement, needs to be clarified.

• A&E need to complete the review of their referral form, adapting a similar layout to

those currently used in Diagnostic Imaging and Nuclear Medicine;

• all written procedures are revised to ensure the appropriate use of terminology,

especially the words ‘justification’ and ‘authorisation’. Words such as ‘normally’ or

‘usually’ should be removed from these procedures; [IRMER Reg 6 Schedule 1(b)];

• the date of when staff obtained a qualification need incorporating into examination

specific written procedures;

• the clarification of role of radiologists / Specialist Registrars (SpRs) is provided in

interventional work;

• written procedures need to reflect the role of assistant practitioners [IRMER Reg 4(2) and Schedule 1].

Page 29: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

25

v) Summary of Noteworthy Practice for Diagnostic Imaging

§ A very clear and comprehensive equipment inventory is in operation, which is

deemed as good working practice.

§ The Imaging Departments referral form, which is clear and easy to use.

§ The use of the Diagnostic open evenings.

§ The completion of the ‘returns log’ by the radiographer/clerical officer to show what

date incomplete request forms were returned, the reasons why and to whom, and

then signatures to show procedure was adhered to.

§ Procedure 10, page 4 has a good clear statement when referring to a possible

Pregnancy. paragraph beginning: ‘If the examination of the pelvis………..’.

§ The department has a good system in place for research trials.

Page 30: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

26

Page 31: Former Conwy and Denbighshire NHS Trust Review of … · Review of Progress against Ionising Radiation (Medical Exposure) Regulations ... were documented on the day of the visit and

27

5. GENERAL THEMES

• Procedures in place try to identify every eventuality rather than describing the norm

and then capturing the exceptions.

• Custom and practice is generally good but is not always captured in policies and

procedures.

• Quality control regarding review and ratification of policies is needed. Need a little

more clarity regarding responsibility at Board level.

• Approach to training seems to be more positive than many areas within the Trust.

• Communication between departments within radiology i.e. between nuclear

medicine and the ‘general department seems to be lacking, following discussions

on the days of the assessment. Amendments to the IRMER Regulations need to be

circulated between both departments.

• Staff seem enthusiastic, motivated and happy to be working within a supportive

team.