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Evidence base

This standard is built on published international guidance, Georgian law and the peer-reviewed evidence base. This page sets out why we use certification, the frameworks we drew on, and the evidence behind the key Standards — together with an honest account of its limits.

Why certification?

Certification is a public recognition by an certification body that a healthcare organisation has met defined standards, demonstrated through an independent external peer assessment[13]. The evidence on its effects is encouraging but should be read with care. A large 2021 systematic review found a consistent positive effect of certification on safety culture, process-related performance, efficiency and patient length of stay, while results for mortality and healthcare-associated infections were mixed[11]. A review across the recognised dimensions of quality similarly concluded that certification may have a positive impact on efficiency, safety, effectiveness, timeliness and patient-centredness[12]. At the same time, a 2023 review emphasised that findings remain inconsistent and that strong evidence of effectiveness is still limited[13], a caution echoed in the Cochrane review of external inspection of standards[14].

We therefore present certification honestly: as a quality-improvement and assurance tool with good evidence for improving processes, culture and organisation — not as a guarantee of clinical outcomes.

The frameworks we drew on

World Health Organization. The WHO Global Patient Safety Action Plan 2021–2030 sets the vision that no one should be harmed in health care and every patient should receive safe, respectful care[1]. WHO guidance on infection prevention and hand hygiene underpins our hygiene Standards — hand-hygiene improvement can prevent a large share of avoidable healthcare-associated infections[2,3].

ISO. ISO 7101:2023 is the first international consensus standard for healthcare quality management, setting requirements for care that is safe, effective, timely, efficient, equitable and people-centred[6]. ISO 9001 and recognised sterilisation standards inform our governance and treatment Standards[7,8].

ISQua / IEEA. The Guidelines and Principles for the Development of Health and Social Care Standards informed how our standard is written, structured and reviewed[9].

Accreditation Canada / HSO. Internationally recognised certification methodology, provided as technical support through the AC Georgia office[10].

Evidence behind the key standards

Reception, information & consent (Standard 2). Grounded in the WHO Declaration on the Promotion of Patients’ Rights in Europe (1994), the European Charter of Patients’ Rights (2002), the Council of Europe Oviedo Convention (1997), and Georgian law, which adopted the Law on Health Care in 1997 and the Law on the Rights of the Patient in 2000[15,16,17,20,21].

Environment, hygiene & infection control (Standards 3–4). Grounded in the WHO Guidelines on Hand Hygiene in Health Care (2009), the WHO core-components guidance for infection prevention and control (2016), and the WHO Global Action Plan on Antimicrobial Resistance (2015)[2,3,4,5].

Care, treatment & sterilisation (Standard 4). Grounded in the Spaulding classification for instrument reprocessing and recognised sterilisation standards, alongside consent requirements in Georgian law[8,19,21].

Safety & emergency preparedness (Standard 5). Grounded in patient-safety guidance and current resuscitation guidelines[1,18].

Governance & management (Standard 7). Grounded in ISO 7101:2023 and the organisational-quality principles of ISQua[6,9].

The full, linked reference for each sub-standard is also shown inside the self-assessment, beside the question it supports.

Limitations

Certification reflects an assessment at a point in time and depends on the accuracy of what a facility declares. The published evidence is heterogeneous, and improvement in processes does not automatically translate into improved clinical outcomes. We state this openly so the public understands what a SheniEkimi mark does — and does not — mean.

References to these organisations describe the external guidance that informed this standard. They do not imply endorsement, sponsorship, certification, affiliation with, or certification by any of these organisations.

References

  1. World Health Organization. Global Patient Safety Action Plan 2021–2030. Geneva: WHO; 2021. ISBN 978-92-4-003270-5.
  2. World Health Organization. WHO Guidelines on Hand Hygiene in Health Care: Clean Care is Safer Care. Geneva: WHO; 2009.
  3. World Health Organization. Guidelines on core components of infection prevention and control programmes at the national and acute health care facility level. Geneva: WHO; 2016.
  4. World Health Organization. Global action plan on antimicrobial resistance. Geneva: WHO; 2015.
  5. Pittet D, Donaldson L. Clean Care is Safer Care: a worldwide priority. Lancet. 2005;366(9493):1246–7.
  6. International Organization for Standardization. ISO 7101:2023 Healthcare organization management — Management systems for quality in healthcare organizations — Requirements. Geneva: ISO; 2023.
  7. International Organization for Standardization. ISO 9001:2015 Quality management systems — Requirements. Geneva: ISO; 2015.
  8. International Organization for Standardization. ISO 17665 Sterilization of health care products — Moist heat. Geneva: ISO.
  9. ISQua External Evaluation Association. Guidelines and Principles for the Development of Health and Social Care Standards. Dublin/Geneva: ISQua EEA.
  10. Health Standards Organization / Accreditation Canada. Qmentum International certification programme. Ottawa: HSO/AC.
  11. Hussein M, Pavlova M, Ghalwash M, Groot W. The impact of hospital accreditation on the quality of healthcare: a systematic literature review. BMC Health Serv Res. 2021;21:1057.
  12. Araujo CAS, Siqueira MM, Malik AM. Hospital certification impact on healthcare quality dimensions: a systematic review. Int J Qual Health Care. 2020;32(8):531–44.
  13. Alhawajreh MJ, Paterson AS, Jackson WJ. Impact of hospital accreditation on quality improvement in healthcare: a systematic review. PLoS One. 2023;18(12):e0294180.
  14. Flodgren G, Gonçalves-Bradley DC, Pomey MP. External inspection of compliance with standards for improved healthcare outcomes. Cochrane Database Syst Rev. 2016;(12):CD008992.
  15. WHO Regional Office for Europe. Declaration on the Promotion of Patients’ Rights in Europe. Amsterdam; 1994.
  16. Active Citizenship Network. European Charter of Patients’ Rights. Rome; 2002.
  17. Council of Europe. Convention on Human Rights and Biomedicine (Oviedo Convention). 1997.
  18. European Resuscitation Council. ERC Guidelines for Resuscitation 2021. Resuscitation. 2021;161.
  19. Spaulding EH. Chemical disinfection of medical and surgical materials. In: Disinfection, Sterilization and Preservation. Philadelphia: Lea & Febiger; 1968.
  20. Parliament of Georgia. Law of Georgia on Health Care. 1997 (as amended).
  21. Parliament of Georgia. Law of Georgia on the Rights of the Patient. 2000 (as amended).
  22. Parliament of Georgia. Law of Georgia on Personal Data Protection. 2023.