Key Details of Recent CQC Inspection and Compliance Process
Discover the timeline and requirements of a recent CQC inspection at a healthcare facility, including requested documents, inspection personnel, and preparation activities. Find out about reported incidents, CEO notifications, compliance notices, and more.
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Presentation Transcript
CQC Inspection CGH October 27th& 28th 2022 Assured it was a Proactive not Reactive Inspection we had 2 open reported incidents Brachytherapy inspection separate from external beam
Timeline CEO notified 13/10/22 ( Thursday) Information requested to be submitted by 12pm Monday 17th Inspection on site 26 &27/10/22 Follow up on teams call 31/10/22 Further documents requested 31/10/22 to be sent by 4pm 1/11/2022 Improvement notice for brachy sent 9/11/2022. Compliance required by 21/12/2022
Initial document list Radiotherapy Inspection Employer s procedures Organisational structure for management of radiation protection Any documentation outlining how IR(ME)R/radiation protection is managed within the organisation Minutes of the last three radiation protection committees (or any other meetings relating to radiation governance) IR(ME)R equipment inventory Document detailing the provision of clinical audit Study of risk for radiotherapeutic exposures A list of radiation incidents for the last 12 months (including those not externally notifiable) Brief overview of number of linacs and set up of radiotherapy department. In addition, please ensure that the following are available for review on the day of inspection: Examination/clinical protocols Training records for all duty holders Equipment performance test results Details of clinical audits Authorisation guidelines (where applicable)
Inspection Requested personnel Below we have included a suggested list of personnel to be present for discussions. However, please invite anyone who plays a key role in IR(ME)R compliance for Radiotherapy and/or Brachytherapy. We understand that staff may have other commitments and can be flexible to accommodate this. Medical Physics Expert and/or Radiation Protection Advisor Radiotherapy leads/service managers Lead clinician for radiotherapy Governance lead
Preparation Ensured all protocols were in date Removed any old documents Delivered staff updates on IR(ME)R Reviewed training records for clinicians, physics and radiographers Reviewed DATIX incidents Prepared useful document folder Datix incidents we hadn t reported according to guidelines eg repeat imaging and themes.
On the day Radiotherapy lead gave introductory talk. (we didn t prepare a brachytherapy specific one for the next day may have been useful) Good engagement with divisional lead and chair of radiation safety committee in attendance 2 inspectors, both radiographer background 1 inspector looked round the dept & spoke to a B5,6 &7 radiographer 1 inspector looked at training records
Reporting incidents We hadn t reported all our incidents Noticed prior to inspection and set up fortnightly Datix review meetings MPE involvement was low No themes reported Going forward formal MPE sign off on all level 1,2&3 incidents
Other comments Not Arsac licences - licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017 Want to see audit programmes including clinical audit Actions following long term absences % radical shortcourses Correct terminology around pregnancy Definition of CSAUE (references correct) Documents correctly formatted page X of Y must be correct) Training records ( rads) to show reflective comments. Patient pathway audits recommended
Other comments Asked if we had enough physicists MPE provision What does significant mean? Need precision Asked about IVD in the dept Liked that we had asked other centres advice Wanted us to share findings Governance structure & link to RSC important Concession in place needed to be clearly displayed Requested we supplied copies of documents that had been discussed during the inspection
Brachytherapy IMPROVEMENT NOTICE Issued under the Health and Safety at Work etc. Act 1974 and the Ionising Radiation (Medical Exposure) Regulations 2017 ( IR(ME)R ) you have contravened the Regulation cited below: Ionising Radiation (Medical Exposure) Regulations 2017, Regulation 11, Justification of individual exposures 11(5) Where it is not practicable for the practitioner to authorise an exposure as required by paragraph (1)(c), the operator must do so in accordance with guidelines issued by the practitioner. at: Cheltenham General Hospital, Sandford Road, Cheltenham, GL53 7AN The reasons for the Inspector s opinion are as follows: During an inspection of the Brachytherapy service at Cheltenham General Hospital on 27 October 2022 we found: The department used a letter listing named unlicensed practitioners, signed by the licence-holding practitioner, to delegate authorisation of brachytherapy procedures, rather than authorisation guidelines as required by the regulations. And I hereby require the said contraventions to be remedied by 21/12/2022
What we had 3 Oncologists Only 1 licence holder Working towards radiographer led authorising Lack of consistency cf external beam Documentation was in place but inadequate Acting as authoriser not practitioner
Post inspection Carried out required actions - Oncologists applying for their own licences Lead Brachy radiographer since left no radiographers are currently authorising any brachytherapy Learning We saw brachytherapy as part of RT overall At the inspection clear separation of the external beam RT and brachy Need to ensure IRMER compliance and evidence - applies to both XRT and brachytherapy Including clinical audits. Notification criteria was updated in April 2023. Going forward are remote visits going to be the standard? Will it change anything?
