A Slovenian Experience in Certification and Quality Labelling of EHRs

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A Slovenian Experience in Certification and
Quality Labelling of EHRs

• Leo Ciglenecki
• EuroRec, vice-president
• Prorec.SI, director
• leo.ciglenecki_at_siol.net

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Content

• Prorec Slovenia Q-REC project
• Workshop with SW industry
• Assisted self validation of SW
• Q-criteria validation
• Results
• Plans
• Focus on SLO experience/workshop

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Prorec Slovenia (Ustanova Prorec.SI)

• Since 2003
• Links with all relevant stake holders
  (authorities, users, industry).
• Industrial forum - recent activities
• A member of the Q-REC project consortia, together
  with partners from 12 EU countries

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Project Q-REC

• Project Q-REC Quality Labeling and
  Certification of Electronic Health Record
  Systems.
• Started in 2006.
• Suported by EC under FP6 IST Programme
• The main objective create an efficient, credible
  and sustainable mechanism for the certification
  of EHR systems in EU and in its member states.

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Workshop (1)

• A workshop for SW vendors organized in April 2008
• Aim
• Q-REC criteria validation
• Assisted self-validation of the SW
• Participation in the interest of both
• SW vendors and Prorec.SI

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Workshop (2)
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Workshop (3)

• Participants
• Three SLO major SW companies (HI)
• (Infonet/SRC d.o.o., List d.o.o., Nova
  Vizija d.o.o.)
• SW supporting Medication management functionality
  (primary HC)
• The workshop led by Prorec.SI representatives

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Workshop (4)

• Pre-agreed
• "This is only a test of Q-criteria, NOT a
  certifying exercise no certificate issued
• "Possible unfavourable results will NOT be
  published
• "Possible favourable results MAY be promoted, but
  without claiming any official Q-Rec/Eurorec/Prorec
  .SI seal or statement
• Note the tested Q-criteria are not yet fully
  refined/grouped/indexed

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Workshop (5)

• Input
• Business function "A10 Medication management /
  Upravljanje z zdravili"
• 226 fine-grained statements from A10.0 A10.6
• A10.0 - Selection Item Content
• A10.1 - Production of a prescription, its
  dispensing and administration
• A10.2 - Decision support medication care
  quality surveillance
• A10.3 - Display, structuring and management of
  medication
• A10.4 - Medication administration
• A10.5 - Medication effects
• A10.6 - Regulatory administrative aspects
• Some examples of the fine-grained statements

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Workshop (6)
The system ENABLES TO ENTER medication items
(GS001549.03)
The system enables to enter that a patient takes
NO MEDICATION at all (GS001584.01)
The system allows FREE TEXT OR UNCODED medication
items if and ONLY IF the medicinal product isn't
available in the coded list of medicinal products
(GS001581.01)
The system CALCULATES THE TOTAL price at the
point of prescription and presents that
information (GS002464.01)
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Workshop (7)

• Translations
• Approx half of the statements already translated
  in Slovenian language
• Dictionary/Thesaurus emerging
• A challenge for future activities in SLO health
  informatics overall

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Workshop (8)

• Assisted self-validation of the SW and
  Q-criteria validation
• Each vendor assessed conformance of their SW
  against Q-REC criteria.
• Possible replies YES, NO, PARTIALY, N/A
• Active dialog with other participants.
• In parallel
• Comments on Q-criteria noted and
• Individual terms added to Dictionary/Thesaurus

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Workshop (9)

• Results SW assessment
• No major SW insufficiencies noticed
• Most of the 'NO replies due to absence of
  conditions, where SW producers have no hold on
  them (state institutions, purchasers,
  infrastructure, code-lists, )
• The overall result satisfying

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Workshop (10)

• Results SW assessment-statistics

3 x YES 26 3 x NO 20
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Workshop (11)

• Results Q-criteria evaluation
• Many new ideas occured to the participants. Extra
  functionalities to be built in their SW.
• Too many ideas!
• Additional grouping/indexing needed (to avoid
  duplications etc..)

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Workshop (12)

• Some statements need explanations (e.g. does a
  statement refer to the application or to the
  code-list...)
• Some terms need definitions (idealistically
  data/object model)
• Precise quality metrics needed
• is it sufficient when SW only enables a
  functionality or
• does it also have to provide all required data /
  knowledge bases.. ...

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Workshop (13)

• Results Certification Organisation and Process
  issues
• The participants suggested
• Pre-assessment to be performed as self-assessment
  
• Main assessment to be performed by an
  independent, state accredited institution
• SW providers willing to pay for the process
• Correlation with results of the earlier
  promotion / questionnaire

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Plan

• To stay in the focus of the EU developments
• Assess possibilities for EHRs Q-labeling and
  certification in Slovenia
• Promotion with health care providers,
  authorities accreditation?

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• Thank you!
• leo.ciglenecki_at_siol.net