Background: We report quality assessment (QA) at each step of organ donation (OD), from the identification of a prospective donor with suspected brain death (BD) to organ retrieval. Methods: Case summaries and files of patients who expired or left against medical advice (LAMA) in 2019 in a 290-bed hospital were studied. Possible, potential, eligible, and actual donors were identified from among those with devastating brain injury (DBI). Potential donors (PDs) were subclassified into five types. The structure, process and outcomes related to OD were evaluated with appropriate Quality Indicators and Quality Criteria. Statistical Analysis: Data were analysed using MS Excel and we have used cross tabulation method for statistical analysis. Results: Of 352 deaths, 324 occurred in intensive care units (ICUs), of which 210 were reported from medical and surgical ICUs. ICD-10 codes relevant to process of OD were found in 27 patients, of whom 16 (7.6% of deaths) received ventilatory support and were possible donors. BD was suspected by ICU teams in 10 patients (4.7% of deaths), labeled as PDs. The presence of nonreactive pupils were recorded in 10 (100%) case files and 5 (50%) death summaries, while other brain stem reflexes were endorsed in 6 (60%) case files and none of death summaries. Rates for referral, contraindication, request, and consent were 80%, 40%, 66.6%, and 50%, respectively. From 20 patients with DBI who LAMA, 11 possible donors and five PDs were identified. Conclusion: Retrieval of data relevant to OD is possible by auditing the available mortality and LAMA records in India. Formatting of death summaries in patients with DBI to include Glasgow Coma Scale and all brain stem reflexes would help in the process of QA for OD.

Organ donation following circulatory determination of death (DCDD) has contributed significantly to the donor pool in several countries, without compromising the outcomes of transplantation or the number of donations following brain death (BD). In India, majority of deceased donations happen following BD. While existing legislation allows for DCDD, there have been only a few reports of kidney transplantation following DCDD from the country. This document, prepared by a multi-disciplinary group of experts, reviews the international best practices in DCDD and outlines the path for furthering the same in India. The ethical, medical, legal, economic, procedural, and logistic challenges unique to India for all types of DCDD based on the Modified Maastricht Criteria have been addressed. India follows an opt-in system for organ donation that does not allow much scope for uncontrolled DCDD categories I and II. The practice of withdrawal of life-sustaining treatment (WLST) in India is in its infancy. The process of WLST, laid down by the Supreme Court of India, is considered time-consuming, possible only in patients in a permanent vegetative state, and considered too cumbersome for day-to-day practice. In patients where continued medical care is determined to be futile following detailed and repeated assessment, the procedure for WLST, as laid down and published by Vidhi Centre for Legal Policy in conjunction with leading medical experts is described. In controlled DCDD (category-III), the decision for WLST is independent of and delinked from the subsequent possibility of organ donation. Once families are inclined toward organ donation, they are explained the procedure including the timing and location of WLST, consent for antemortem measures, no-touch period, and the possibility of stand down and return to the intensive care unit without donation. While donation following neurologic determination of death (DNDD) is being increasingly practiced in the country, there are instances where the cardiac arrest occurs during the process of declaration of BD, before organ retrieval has been done. Protocol for DCDD category-IV deals with such situations and is described in detail. In DCDD category V, organ donation may be possible following unsuccessful cardiopulmonary resuscitation of cardiac arrest in the intensive care. An outline of organ-specific requisites for kidney, liver, heart, and lung transplantation following DCDD and the use of techniques such as normothermic regional perfusion and ex vivo machine perfusion has been provided. With increasing experience, the outcomes of transplantation following DCDD are comparable to those following DBDD or living donor transplantation. Documents and checklists necessary for the successful execution of DCDD in India are described.