ir(me)r 2000 healthcare commission activities
TRANSCRIPT
IR(ME)R 2000
Healthcare Commission activities & likely future approach
Cliff Double, IR(ME)R Lead
Healthcare Commission
22nd May 2008, RCR
Overview of Activities
1. Developed new reporting system via web-forms with DH and HPA assistance
2. Enrolled ‘generalist’ Assessors as IRMER inspectors + training with HPA assistance
3. Held workshops
4. Recruited staff into IRMER related areas
5. Determined inspection priorities – proactive and reactive
6. Located IRMER alongside other HCC activities
Inspection Two types of Activity – Reactive and Proactive
Reactive Inspections
Escalation In response to a notification of an incident under reg. 4(5) or from concerns raised by public
The Department of Health (DH) and Health Protection Agency (HPA) advised and reviewed our escalation decision-making to ensure that appropriate actions are taken to safeguard patients and to ensure a consistency in approach.
Proactive Inspections
Consistent with our proportionate risk-based approach to regulation
Screening and surveillance has informed the inspection programme for risk-based visits but selection mainly random for 2007/08
Assessment of high risk installations (e.g. radiotherapy departments) twice in each five year period
Notifications to the Healthcare Commission (1)
via the web based notification form
http://www.healthcarecommission.org.uk/ serviceproviderinformation/irmer2000.cfm
each notification is given a unique IRMER reference number as it is automatically logged onto the HC IT system
The IRMER Ref. No. is quoted in all correspondence
Notifications to the Healthcare Commission (2)
Notifications are received by the IR(ME)R Notifications Officer (Malcolm Ramsdale) or the IR(ME)R Coordinator (Jo Riggs)
The ‘local’ HC Assessor with the establishment on her/his caseload receives a copy of the notification for their information
A file is raised for each notification in which all subsequent process, correspondence and decisions are recorded
All notifications are triaged by the IR(ME)R Lead Inspector/Associate IRMER inspector
Notifications to the Healthcare Commission(3)
All incidents are recorded and assessed against a risk matrix which leads to three possible outcomes
►Additional information requested
Queries on a notification are likely to be by email or telephone
►Decision to undertake an inspection
Where an escalation is required, usually immediate, in order to investigate the incident
► No further action
The file on a notification is ‘closed’. This is always in writing to the Chief Executive of the organisation with a copy to the notifying person
Are the patient & Chief Exec informed?15-month data
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan
2006 2007 2008
Year/Month
Perc
en
tag
e
Chief Executive Informed Patient Informed
Delay to notification to HCC
0
20
40
60
80
100
120
140
160
180
<0
0-1
4
15-2
9
30-4
4
45-5
9
60-7
4
75-8
9
90-1
04
105-1
19
120-1
34
135-1
49
150-1
64
165-1
79
180-1
94
195-2
09
210-2
24
225-2
39
>240
Delay (Days)
Fre
qu
en
cy
Total to Date Last Quarter March
Month-by-Month variation of notifications made to us
0
5
10
15
20
25
30
35
40
45
50
Novem
ber
Decem
ber
January
Febru
ary
Marc
h
April
May
June
July
August
Septe
mber
Octo
ber
Novem
ber
Decem
ber
January
Febru
ary
Marc
h
Month
ly A
vera
ge
2006 2007 2008
Who makes the report to us?
19%
1%
50%
30%
Corporate Management
Medic
Radiography
Scientist
Notifications1st Nov ‘06 to 31st March ’08(17-month report)
Total of 408 notifications:
292 in radiology
30 in Nuclear Medicine
86 in radiotherapy
From 119 establishments (two reporting 22 times), 12 from the independent sector, 2 from PCTs, rest from Acute NHS Trusts.
Reports by modality – over 15 months with context of latest available month (January 2008)
March 2008
50%
5%
45%Diagnostic
Nuclear Medicine
Radiotherapy
Quarter 1 2008
66%9%
25%
Diagnostic
Nuclear Medicine
Radiotherapy
Total to Date (End of March)
72%
7%
21%
Diagnostic
Nuclear Medicine
Radiotherapy
Notifications from RT Departments
Employers are obliged to investigate where an incident has occurred or may have occurred in which a person has been exposed to ionising radiation to an extent ‘much greater than intended’
Unless the preliminary investigation shows that no such exposure has occurred, then the Healthcare Commission must be notified and the employer must make or arrange for a detailed investigation of the circumstances of exposure and an assessment of dose received.
Reporting categorised ‘Treatment’, ‘Planning’, ‘Referral’.
What type of error led to notifications in radiotherapy?
Total to Date (End of March)
42%
56%
2% 0%
Beam therapy palliative
Beam therapy radical
Brachy therapy radical
Brachy therapy palliative
Total to Date (End of March)
26%
11%59%
4%
Planning error
Referral error
Treatment error
Other
Quarter 1 2008
50%50%
0%
0%
Beam therapy palliative
Beam therapy radical
Brachy therapy radical
Brachy therapy palliative
Quarter 1 2008
45%
10%
45%
0%
Planning error
Referral error
Treatment error
Other
Proactive Inspection Programme in RadiotherapyCommitment to provide 2 assessments in 5 years for all radiotherapy departments.
Inspections began in July 2007 – have completed all 22 to before end March 2008 as committed to management.
Currently considering alternative ways of delivering the assessments. Collaborating with HPA/HIW to develop self-assessment methodology consistent with mainstream HC work.
Inspections carried out to date have been randomly selected. Future inspections will be risk-based, and may include those departments which have not notified under reg. 4(5), those who have made a number of notifications, or those which ‘stand out’.
Proactive Inspections in Radiotherapy – inspection arrangements4- 6 weeks notice (announced inspection)
Require to see documentation, propose schedule, ask to have specific staff available during the day, assess compliance against regulations and check understanding on the ground
Provisional outcomes shared on the day, with draft report to follow (to allow hospital to check for factual accuracy).
The final report will be agreed, internally-governance approved and published by HC on web.
Overall findings of compliance to be published separately.
Proactive Inspections of Radiotherapy departments – key findings (1)In first year we cast our net wide to include all regulations 4 – 11.
Overall good compliance to IRMER
Clear, well-defined responsibilities of duty-holders in general
Variable understanding of doses arising from imaging exposures
Management of procedures and clinical protocols within QMS – review frequency variable
Proactive Inspections of Radiotherapy departments – key findings (2)Variable governance / adoption of Employers procedures by him/her
An appreciation of significance of signatures (e.g. of practitioner)
Documentation of ‘Operator’ training of clinical oncologists
Assurances concerning registration status of key duty holders
IRMER responsibilities in abstentia (e.g. planned and unplanned leave)
Closed notifications categorised as ‘Treatment’
26 Treatment Errors (23 linac, 3 ortho-voltage)
1. Majority involved misinterpreting set-up instructions on treatment form
2. Many involved use of the incorrect reference tattoo
3. Some involved incorrect shielding, or wrong cut-out
4. Some involved transcription errors of FSD
Closed notifications categorised as ‘Referral’ or Medical-staff initiatedSmall number of examples includes:
1. Specialist Reg. did not wait for radiologist report on MRI brain scan before prescribing palliative treatment
2. Incorrect target volume drawn without subsequent challenge
3. Use of Infinity Protocol without adequate review
4. Incorrect dose / fractionation prescribed
5. Mis-transcription of nodal status from patient notes
Closed notifications categorised as ‘Planning’
19 Planning errors led to exposures MGTI:
1. Majority were calculation errors without adequate checks
2. Some transcription errors without adequate checks
3. Some treatment planning with patient planned in non-standard treatment position or last-minute changes not documented
4. Some CT-simulation of wrong anatomy.
Notifications from Radiotherapy Depts.50 Centres in England:
Number of Notifications made by Numbers of RT organisations
8 1
7 1
6 0
5 0
4 5
3 9
2 5
1 15
0 15
Response to notifications made to HC
We need to know:
Was the organisation Chief Executive informed?
Was the patient (or relative) informed?
In order to close need to ensure how the notification was:
escalated – clinical risk meetings, RPC
reviewed – procedures, training, learning assured
Impact on patient
Internal witness statements collected
Inclusion of outside experts in review
How quick is a notification required? We are developing guidance.
Healthcare Commission’s outline inspection priority areas for 2008-910 More inspections of radiotherapy departments
Will pilot self-assessments of radiotherapy departments to help risk-assessment of radiotherapy departments
Will pilot self-assessment of nuclear medicine and radiology departments (though this will not identify candidates for proactive inspection)
Concerns in Chiropractic (quality, appropriateness of the justification)
Concerns in Dental (numbers of x-rays taken c. 14 million annually)
‘Self initiated’ CT scans, following COMARE 12 report
Other ‘high-dose areas’, including cardiology, nuclear medicine
MoU with HPA under development for formalise information sharing