Accreditation

Accreditation

• 1.
  QCI, NABH, NABL& Eye Banking in India Prof R Tandon, RPC, AIIMS Hon Vice President Eye Bank Association of India [Radhika Tandon] [Professor of Ophthalmology & Faculty in Charge National Eye Bank] [Dr Rajendra Prasad Centre for Ophthalmic Sciences] [AIIMS]
• 2.
  EBAI & ItsRole in Eye Banking • Vision: ▫ To create an effective eye banking system so as to eliminate avoidable corneal blindness in India and in the developing world. • Mission: ▫ To advance eye banking through development of effective educational and training programs, advocacy and quality assurance programs.
• 3.
  Key Strategies Advocacy a)Legislation changes passing of bill proposing amendments to Transplantation of Human Organs Act to include – Required Request and allowing Trained Technician to enucleate. THOA amendment 2011 THOTA b) Public awareness: c) HCRP: Advocate efficacy of hospital based programs Eye Banks & Eye Donation centers,to yield more results with introduction of ‘Required Request Law’.
• 4.
  Key Strategies Accreditation •EBAI approached GOI ▫ for Recognition as Accreditation authority • QCI ▫ Associations cannot certify accreditation for its own members Proliferation of sub-standard eye banks can be curtailed by Accreditation and would gradually lead to eye banks adopting the three tier model. EB EDC EBTC
• 5.
  Key Strategies ZonalTraining Centers • Human resources & infrastructure • Focus on training Technicians and EDCs • Eye Bank Managers • Corneal surgeons.
• 6.
  Key Strategies: Development •Networking: • Eye Banking • Unique requirements • Requires improvisation in practices and methods • Optimize available resources. • Facilitate networking with various professional training organizations as well as peer groups / agencies in eye banking and Organ banking in different parts of the World • MOU for accreditation pilot project ORBIS-SightSavers-SightLife • MOU for Strengthening EB services SightLife • Training Modules: • Technicians • Eye Donation Counselors • Eye Bank Managers
• 7.
  Challenges 8 EyeBanks in India participated  infrastructure, resources, performance , geographic location  ‘Trial run’  Training process  Validate the adaptation of a hitherto ‘alien’ concept  Revise policies and procedures as appropriate EBAI-SightLife-ORBIS-SightSavers
• 8.
  Challenges MOU signedEBAI-NABH  Next Steps  Policies and procedures to peer review  Policies and procedures to QCI
• 9.
  Challenges Finalize policiesand procedures  Medical Directors  Accreditation Assessors  Next Steps  Inputs  Discussion  Output
• 10.
  Challenges EBAI becomea wing of AIOS  EBAI Annual CME  EBAI session at AIOS
• 11.
  [Is corneal tissuebeing transplanted at par with the best in the world?.]
• 12.
  National Standards EBAI-NPCB MedicalStandards Document 1999 Hyderabad LVPEI 2009 Delhi ORBIS International
• 13.
  Overview • Background • NationalConsultation • Review • Publication
• 14.
  Implications Quality & Credibility Medical Tourism Export
• 15.
  Why Review &Update • Dynamic Process • At par with best of the rest of the world • Changing recommendations • Keep up with changing Regulations ▫ THOTA ▫ NABH ▫ Clinical Services Establishments  Eye Donation Centre/Bank/Transplant Centre
• 16.
  Current Standards ofEye Banking in India • Technical • Administrative • Practical • Operational
• 17.
  Adopting & AdaptingStandards • International Eye Banking Technical Advisory Group on Nomenclature, Coding and Labelling of Ocular Tissue ▫ The Global Standard for Medical Products of Human Origin ▫ ISBT 128 ▫ International Council for Commonality in Blood Banking Automation ICCBBA • EBAA FDA • UKTS NHS • EBAANZ EU-Directive • ACS • PAAEB • EEBA-EU Tissues & Cells Directive • EBAI NPCB/NABH/DCGI-FDA
• 18.
  Alignment • THOTA ▫ Rules ▫Guidelines ▫ Legal Registration ▫ Accreditation • CEA - http://clinicalestablishments.nic.in/En/1061-act-page.aspx ▫ NABH to finalize the blood/organ/eye/tissue standards ▫ Accreditation  Eye Donation Centre/Bank/Transplant Centre • NABH
• 19.
  Key Areas ofFocus • Scope of Document • Content • Specific Areas ▫ Serological testing technique ▫ Death to preservation time ▫ Equipment ▫ Microbiology ▫ Media, storage, distribution ▫ Consent forms ▫ Authenticity of cause of death ▫ ‘Technicians’
• 20.
  Questions Dr Rajendra PrasadCentre for Ophthalmic Sciences, AIIMS
• 21.
  Thank You Dr RajendraPrasad Centre for Ophthalmic Sciences, AIIMS
• 22.
  Resources • National EyeBank NPCB • EBAI QCI Thank you!