IRMER 2000 Healthcare Commission activities

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IR(ME)R 2000Healthcare Commission activities
likely future approach

• Cliff Double, IR(ME)R Lead
• Healthcare Commission

22nd May 2008, RCR
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Overview of Activities

• Developed new reporting system via web-forms with
  DH and HPA assistance
• Enrolled generalist Assessors as IRMER
  inspectors training with HPA assistance
• Held workshops
• Recruited staff into IRMER related areas
• Determined inspection priorities proactive and
  reactive
• Located IRMER alongside other HCC activities

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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

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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

IRMER_at_healthcarecommission.org.uk
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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

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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

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Are the patient Chief Exec informed?15-month
data
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Delay to notification to HCC
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Month-by-Month variation of notifications made to
us
 
 
 
 
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Who makes the report to us?
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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.

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Reports by modality over 15 months with context
of latest available month (January 2008)
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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.

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What type of error led to notifications in
radiotherapy?
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Proactive Inspection Programme in Radiotherapy

• Commitment 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.

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Proactive Inspections in Radiotherapy
inspection arrangements

• 4- 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.

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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

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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)

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Closed notifications categorised as Treatment

• 26 Treatment Errors (23 linac, 3 ortho-voltage)
• Majority involved misinterpreting set-up
  instructions on treatment form
• Many involved use of the incorrect reference
  tattoo
• Some involved incorrect shielding, or wrong
  cut-out
• Some involved transcription errors of FSD

20
Closed notifications categorised as Referral or
Medical-staff initiated

• Small number of examples includes
• Specialist Reg. did not wait for radiologist
  report on MRI brain scan before prescribing
  palliative treatment
• Incorrect target volume drawn without subsequent
  challenge
• Use of Infinity Protocol without adequate review
• Incorrect dose / fractionation prescribed
• Mis-transcription of nodal status from patient
  notes

21
Closed notifications categorised as Planning

• 19 Planning errors led to exposures MGTI
• Majority were calculation errors without adequate
  checks
• Some transcription errors without adequate checks
• Some treatment planning with patient planned in
  non-standard treatment position or last-minute
  changes not documented
• Some CT-simulation of wrong anatomy.

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Notifications from Radiotherapy Depts.50 Centres
in England
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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.

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Healthcare Commissions outline inspection
priority areas for 2008-9

• 10 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