Quality Control for Clinical Interpretation

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Quality Control for Clinical Interpretation

• A Scheme for Virology
• Prof. G Kudesia

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Existing Quality/Audit Schemes in UK

• NEQAS
• National External Quality Assessment Scheme
• IQC
• Internal Quality Control
• IQA
• Internal Quality Assessment
• CPA- UK
• Clinical Pathology Accreditation- UK
• Test the technical processes, IQA and CPA attempt
  to assess clinical interpretation/input but not
  on an individual basis.

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Trust, Assurance and Safety the Regulation of
Health professionals-regulation of Health
Professionals in the 21st Century (2007)- DoH

• Revalidation
• Relicensing
• Recertification
• College through setting standards, arranging
  assessments

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Quality/Audit Schemes in UK for Clinical
assessment

• Histopathology
• Clinical Chemistry

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Scheme for Clinical Chemistry

• Web based scheme
• Clinical scenario with set of results given out
• Each participant has a code
• Length of comments limited to 200 characters-
  longer comments automatically rejected and not
  scored
• Participant replies are scored and individual
  score with average scores for scenario sent as
  feedback

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Scoring of Comments

• Score is on a scale from -1(inappropriate) to 3
  (highly appropriate).
• Scoring is done by a panel of assessors-average
  score of individual reported.
• Marks are for adding value, therefore higher
  the score higher is the added value of comment

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Clinical Quality/Audit Scheme for Virology

• Potential scheme for Virology (Examples)
• Result(s) Interpretation
• Advice on Clinical Scenario
• Result(s) Interpretation Clinical Scenario
  Advice

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Sheffield Clinical Interpretation Scheme

• SCIQAS

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Pilot Clinical Quality Assessment Scheme

• Ran a Pilot Scheme through Clinical Virology
  Network UK, November 2004 of 6 clinical scenarios
  results for interpretation.
• Voluntary, anonymous participation
• Not Scored BUT
• All replies were collated and circulated to the
  participants so they could judge their own
  statements against those of their peers.

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From Pilot QA to SCIQAS- Sheffield Clinical
Interpretation Quality Assessment Scheme

• E mail administration through the CVN UK email
  system
• Two clinical scenariosresults bimonthly
• Reply limited to 200 words
• Room to add further tests/investigations as
  appropriate
• Replies sent to administrator who after
  anonymising them passed them to GK
• Analysis of replies done and circulated back
• discrepancies highlighted

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SCIQAS Time Table
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Current Scheme-since 2006

• Open to virologists in CVN Network Member
  laboratories
• Clinical Scenario sent
• By SCIQAS Team
• Replies collated and analysed and analysis fed
  back to the participants.
• By SCIQAS Team
• Discrepancies highlighted and evidence for and
  against the differing opinion(s) circulated as
  feedback to participants.
• By SCIQAS Team

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Current Scheme-continued

• Web Based- CVN web-sit
• All members have pass word- pass word protected
• Accredited by Royal College of Pathologists for
  participation- 2 CME points per distribution.

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Issues with Current Scheme

• Clinical Scenarios
• Need to generate 12/year- nature of the clinical
  scenario has evolved over the period of time.
• Need to be explicit, (not) ambiguous!
• Evidence based feed back (as expert or literature
  based review) required on the scenarios.
• Collation and Analysis of Replies
• By SCIQAS Team-onerous commitment
• Make all replies accessible anonymously to
  participants
• ? Participation Fatigue
• Falling number of participants
• No discussion on discrepant action/advice- by
  participating CVN members
• Active discussion on message board will add to
  the educational element of the scheme.

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2007 cases
Overall submissions from 10 SVC, only 4 SVC have
made submissions gt 1
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Resultclinical scenario

• CLINICAL INFORMATION Patient attending local
  drug and alcohol support clinic. The result is
  anti-HCV positive. You note that the lab received
  a previous sample from the same patient dated 7th
  July 2006, which was reported as anti-HCV
  negative.Please advise on further management and
  investigation that should be done.
• SAMPLE SUBMITTED Venous blood
  dated14/02/2007 07/07/2006
• INVESTIGATION REQUESTED HCV
• RESULT
• 14/02/07- Anti-HCV positive by two different
  EIAs and RIBA
• 07/07/2006- Anti- HCV negative
• FURTHER TESTSAdvised/added
• CLINICAL COMMENTS

• CLINICAL INFORMATION 18 months old baby.
  Diarrhoea since a week before Christmas,
  continues to have loose sloppy stools. Not
  investigated initially, fist stool specimen
  submitted on 19/01/07. Two other family members
  developed diarrhoea end of January, no specimens
  submitted. Continued diarrhoea in the baby. Baby
  to start in crèche from 1st March 2007.
• SAMPLE SUBMITTED Stool samples
  dated19/01/0702/02/0725/02/07
• INVESTIGATION REQUESTED Rotavirus
• RESULT
• 19/01/07- Rotavirus antigen positive by latex
  test.
• 02/02/07- Rotavirus antigen positive by latex
  test,
• 25/02/07- Rotavirus antigen positive by latex
  test.
• Negative culture for Salmonella, Shigella,
  Campylobacter, E coli 0157, ryptosporidium
  oocysts not seen. . Adenovirus 40/41 antigen
  negative by EIA on all 3 specimens
• FURTHER TESTSAdvised/added
• CLINICAL COMMENTS

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Improving Participation .

• Participation in a clinical quality assessment
  scheme for revalidation to demonstrate
  competence
• Extension to non-CVN Laboratory members
• Personal membership of CVN- includes access to
  the SCIQAS through the CVN web site.
• Open to all interested Microbiologists/Virologists
  with in UK, Europe and outside.

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Improving participation/access-Clinical
Interpretation/advice and Virology NEQAS UK

• Add clinical interpretation element to the NEQAS
  distribution
• Will not measure individual performance

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Purpose of clinical interpretation schemes?

• Educational?
• Assessment?

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Integration of SCIQAS into Clinical Virology
Practice- Educational First

• Disseminate -publish the clinical scenarios and
  expert feedback/review J Clin Virol
• Clinical practice standardised through the SCIQAS
  process-high light agreements/discrepancies
• Development of Clinical Algorithm/practice-evidenc
  e based
• Standardised Clinical Algorithms/practice posted
  on CVN Web site
• Subsequently Score?

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Score or Not to Score

• Participant Replies Not Scored
• Purpose of scheme purely educational
• Score Participant Replies
• Is a pre-requisite by definition for QA schemes
• Use of scheme by participants for revalidation
  purposes will require the participant comments to
  undergo some form of assessment

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Scoring for the Schemes

• Comments assessed and scored for added value
• By a panel of assessors- As per Clinical
  Chemistry Scoring Scheme
• Comments assessed against a Model Comment
• Produced in advance by an expert (or a panel)

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How Scoring might work

• Clinical
• High Vaginal Swab submitted for investigation
  from a 6 year old girl with suspected child
  sexual abuse.
• Results
• Chlamydia Cell Culture - NEGATIVEChlamydia DNA
  by Nucleic acid amplification testing DETECTED
  (CONFIRMED)

• Evidence of Chlamydia trachomatis infection.
  However as the cultures are negative, this may
  not be acceptable as evidence of infection for
  legal purposes. Chlamydia infection confirmed by
  positive culture would at best provide only
  circumstantial, and not direct evidence of child
  sexual abuse. Case reports exist of non-sexual
  chlamydia transmission within families(1) due to
  poor hygiene, and depending on the childs age,
  persistent infection following vertical
  transmission. It would be pertinent to screen and
  treat the mother.

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Microbiology Clinical Interpretation Scheme

• Virology scheme is being adapted
• Professionally Led- by Dr E Brown, Chair of
  NEQAS Microbiology Advisory Group
• Will be delivered and managed by NEQAS UK web
  based-log on will be required
• 12 clinical scenario, similar format to virology
  scheme, not be scored, feed back gold standard
  interpretation anonymised replies from all
  participants will be made available.
• Possible October 08 start date-funding issues
  etc. need to be sorted for the host organization.

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SCIQAS Panel and AcknowledgementsWebsite-
www.clinical_virology.uk.org

• Professional Contributors
• Prof William Irving
• Dr Celia Aitken
• Dr William Carman
• CVN Executive Committee Members
• Administrative Staff
• Lynn Duncombe
• Graeme OMay
• Joy Keane

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Future.

• Assessment of clinical competencies is here to
  stay!