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Compliance with HTA Regulations: The Corneal Transplant Service – Eye Banks’ Strategy

Compliance with HTA Regulations: The Corneal Transplant Service – Eye Banks’ Strategy. CTS Manchester Eye Bank. History. The Corneal Transplant Service (CTS) was launched in October 1983 by the former UK Transplant Service with support from the Iris Fund for the Prevention of Blindness

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Compliance with HTA Regulations: The Corneal Transplant Service – Eye Banks’ Strategy

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  1. Compliance with HTA Regulations: The Corneal Transplant Service – Eye Banks’ Strategy CTS Manchester Eye Bank

  2. History • The Corneal Transplant Service (CTS) was launched in October 1983 by the former UK Transplant Service with support from the Iris Fund for the Prevention of Blindness • In March 1986, the CTS Bristol Eye Bank issued its first corneas for transplantation • CTS Manchester Eye Bank followed in 1988

  3. History • These eye banks were established specifically to increase the CTS distribution of ocular tissue for transplantation by storing corneas in organ culture • This extended corneal storage from just a few days to four weeks

  4. Guidance • The CTS service is overseen by: • The UKT Ocular Tissue Advisory Group (OTAG) and • The Ocular Tissue Transplant Standards Group (OTTSG) of the Royal College of Ophthalmologists (RCOphth).

  5. Further government and professional regulations and guidance • Human Tissue Authority • UK Blood Services • Royal College of Ophthalmologists • British Association for Tissue Banking • European Eye Bank Association

  6. Communication • CTS-EBs Bristol–Manchester bi-annual meeting: • UKT, OTAG, OTTSG, NRC • CTS-EBs, UKT and NRC • OTTSG: Mr Francisco Figuereido • OTAG: Mr Stephen Kaye

  7. Clinical advice • Clinical advisor: Corneal consultant

  8. Road to HTA compliance • CTS-EBs inspected and accredited by MHRA in 2004 • Quality System • SOPs • Audits • HTA input

  9. Donation Consent, patient assessment and next-of-kin interview obtained by trained staff NHSBT, Tissue services, Tissue transplant coordinators Eye retrieval-scheme centres (8) and organ transplant coordinators

  10. Donation Tissue coordinator Trained eye retriever hospital mortuary, hospice, nursing home Donor sites 3rd party agreement Sign TPA with CTS-EBS

  11. Donation • Eye retriever • Site risk assessment • Inform UKT duty office of retrieval • Duty office organise transport of tissue (Contract with TNT)

  12. Eye Bank: Processing • Cleaning the remains of the tissue • Bathing the globes in 2 x NaCl, 1 x 3%PVP, 1 x thiosulphate, final 2 x NaCl • Excising the corneoscleral discs

  13. Eye Bank: Storage • Suspending the corneoscleral disc on the suture • Placing the disc in the organ culture • Incubating for up to 28 days at 340C

  14. Testing and Quality • Virology testing • Microbiology testing: 7 days • Secondary microbiology test • Medical history • GP report Release from quarantine

  15. Corneal endothelial assessment Very good cornea, no dead cells, little folding, >2800 cells/mm2

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