|Year : 2022 | Volume
| Issue : 4 | Page : 377-383
Quality assessment and outcomes related to deceased organ donation in a tertiary care hospital in India an observational study
Avnish Kumar Seth, Twinkle Singh
Fortis Memorial Research Institute, Sector 44, Gurugram, Haryana, India
|Date of Submission||15-Dec-2021|
|Date of Acceptance||09-Jun-2022|
|Date of Web Publication||30-Dec-2022|
Dr. Avnish Kumar Seth
Fortis Memorial Research Institute, Sector 44, Gurugram - 122 002, Haryana
Source of Support: None, Conflict of Interest: None
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.
Keywords: Audit, deceased organ donation, organ donation, quality assessment
|How to cite this article:|
Seth AK, Singh T. Quality assessment and outcomes related to deceased organ donation in a tertiary care hospital in India an observational study. Indian J Transplant 2022;16:377-83
|How to cite this URL:|
Seth AK, Singh T. Quality assessment and outcomes related to deceased organ donation in a tertiary care hospital in India an observational study. Indian J Transplant [serial online] 2022 [cited 2023 Feb 8];16:377-83. Available from: https://www.ijtonline.in/text.asp?2022/16/4/377/364611
| Introduction|| |
The World Health Organization (WHO) has called upon all countries to pursue self-sufficiency in organ transplantation, both by decreasing disease burden and increasing availability of organs., Global Observatory on Organ Donation (OD) and Transplantation data indicate that 12,666 organ transplants were carried out in India in 2019, next only to United States and China. Majority of transplants in India were done from living kidney and liver donors and only 2060 (16.3%) from deceased donors. In India, the process of donation after brain death (BD), more recently called donation after neurological determination of death (DNDD), is fairly well established with relevant legislation in 1994 and 2011 and increasing public awareness. However, In 2019, there were only 715 DNDDs and the donation rate remains low at <1 per million population. It is felt that most hospitals could do more toward increasing OD.
The process of achieving excellence in delivering patient care has evolved from quality control to quality assurance to continuous quality improvement. The process of OD following DNDD involves several steps from identification of a prospective donor to organ retrieval [Figure 1]. Quality assessment (QA) at each step is important for the identification of gaps and continuous improvement. We recently described the Seth-Donation of Organs and Tissues score, a scoring system for assessment of hospitals for best practices in organ and tissue donation. Quality indicators (QIs) are standardized, evidence-based measures of health-care quality that can be used with readily available hospital data to measure and track clinical performance and outcomes. The methods used for QA need to embrace the social, medical, and legal fabric of the country. We present a study on QA of a hospital for OD and describe the QIs related to the structure, process, and outcomes of DNDD, as relevant to India.
|Figure 1: Steps in the process of organ DNDD with suggested terminology and possible areas for improvement. DNDD: Donation after neurological determination of death|
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| Methods|| |
All deaths recorded in the calendar year 2019 in a 290-bed tertiary care hospital based in Gurugram, India, were studied. The hospital is a part of a chain of 18 transplanting hospitals in the country. The Department of Fortis Organ Retrieval and Transplant (FORT) oversees training implementation of standard operating procedure related to DNDD. Furthermore, every death in hospital is tracked and the family counseled for cornea donation (CD) by trained nursing staff as per “IDEAL protocol.” The system, fairly sensitized over 10 years, considers OD and CD a routine part of end of life care.
We selected QIs as relevant to India from two standards available globally: the DOPKI project (Improving the Knowledge and Practice of OD) and the ODEQUS project (OD European Quality System), involving experts from 16 European countries, that identified 123 QC and 31 QIs in the all types of deceased and living OD.,, Following approval from the head of medical administration, details of patients who died during the year were obtained from the medical records department (MRD). From the deaths in intensive care units (ICUs), a team comprising an expert in OD and a TC identified the possible, potential, eligible, and actual organ donors, as defined by the WHO.
Electronic records obtained from MRD as “death register” contained demographic details, diagnosis with ICD codes, and date and place of death. Patients with death due to devastating brain injury (DBI) as a result of head trauma, stroke, anoxic brain injury, or brain tumor, with ICD codes relevant to DCDD [Table 1], were identified. Those who received ventilatory support were picked up from “intubation data” maintained by nursing staff in ICU and identified as possible donors. The OD potential of the hospital was calculated using the following QIs:
|Table 1: List of codes from international classification of diseases that are relevant to deceased organ donation|
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- Possible donors divided by all deaths × 100
- Possible donors divided by deaths in all ICUs × 100
- Possible donors divided by deaths in relevant ICUs × 100.
Death summaries and case files of possible donors identified above were obtained from MRD and studied to identify potential donors (PD), defined as patients in whom BD was suspected by ICU team, irrespective of whether formal testing for BD was carried out or not. The diagnosis of PDs, based on endorsement of the finding of nonreactive pupils with or without absence of other brain stem reflexes in a patient with DBI on ventilator, was established from both death summaries and case files. PDs were classified into five categories as follows:
- PDs identified (PDI): Identified by ICU team but not yet referred to OD committee (ODC), comprising chiefs of medical administration, critical care, and nursing
- PDI and referred (PDIR): Identified and referred to ODC
- PDs with contraindications (PDC): Identified and referred to ODC, but with contraindications to OD including age 80 years and above, mention of sepsis in death certificate, and those with malignancy over the last 5 years
- PDs tested (PDT): Identified, referred to ODC, no contraindications to OD, and in whom the first set of tests for diagnosis of BD were carried out
- PDT and confirmed (PDTC): When both sets of tests confirm BD.
The QIs studied for PDs included the following:
- Number of PDs divided by all deaths × 100
- Number of PDs divided by deaths in all ICUs × 100
- Number of PDs divided by deaths in relevant ICUs × 100
- Referral rate: Number of patients referred to ODC divided by PDs × 100
- Contraindication rate: Patients with contraindication to OD divided by PDs × 100
Approaching family for consent for organ donation
The family was approached for OD by a team comprising transplant coordinator (TC) and hospital administration with representatives from treating and ICU teams available for technical inputs, when required. The following QIs were studied:
- Request Rate: Number of families requested for OD divided by PDs not referred to ODC + PDTs × 100
- Consent Rate: Families consenting to OD divided by PDs not referred to ODC + PDTs × 100
Eligible donors and actual donors
Eligible donors were those where BD was confirmed following the two sets of tests and the family consented to OD. The QIs studied included the following:
- Eligible donor rate: Number of eligible donors divided by PDTs × 100
- Actual donor rate: Number where incision made for organ retrieval divided by PDTs × 100
Left against medical advice
The list of left against medical advice (LAMA) patients was collected from admission register of surgical and medical ICUs and also the billing department. Those with DBI were identified. Ventilation record was obtained from the register maintained by nursing staff in each ICU to look for possible donors. Discharge summary and medical case files of these patients were reviewed to identify PDs with Glasgow Coma Scale (GCS) of three or less and absent brain stem reflexes.
Variables were presented as numbers and frequencies (percentage). Appropriate statistical tests were used.
Declaration of patient consent
The patient consent has been taken for participation in the study and for publication of clinical details and images. Patients understand that the names and initials would not be published, and all standard protocols will be followed to conceal their identity.
The study has been approved by Institutional ethics committee of Fortis Memorial Research Institute, Gurugam, Haryana (Ethics Committee registration no: ECR/223/Inst/HR/2013/RR-16). The study was carried out in accordance with principles of Declaration of Helsinki.
| Results|| |
Of 352 deaths during the study period, 324 occurred in ICUs. A total of 210 deaths were reported from medical and surgical ICUs [Table 2]. ICD codes relevant to the process of DNDD were found in 27 patients. This included cerebrovascular accident (CVA) in 20, head trauma in 3, cerebral neoplasm in 3, and hypoxic brain injury due to hanging in 1 patient. Sixteen of these patients received ventilatory support and were possible donors. BD was suspected by the ICU team in 10 patients and these were labeled as PDs [Figure 2]. The presence of nonreactive pupils was recorded in all 10 (100%) case files, but in only 5 (50%) death summaries. Absence of other brain stem reflexes like gag reflex and corneal reflex was endorsed in 6 (60%) case files, but in none of the death summaries.
|Figure 2: Flowchart showing deaths, Possible Donors, Potential Donors and outcomes in donors following neurological determination of death|
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Of 10 PDIs, two were not referred to the ODC, and the reason for the same could not be ascertained from the file. Eight PDs were referred to ODC (PDIR). Four of them had contraindication to OD (PDC) including age above 80 years in 2, sepsis in 1, and leukemia in 1 patient. Four PDs were referred to the ODC for formal testing for BD (PDT) and the first set of tests were suggestive of BD in all. Families of all four were counseled and 3 (75%) consented to OD. The second set of tests for BD were done in all three. In two of the three eligible donors, organ retrieval could not be done due to issues with medicolegal clearance in one and demand for directed deceased donation in the other. There was one actual donor where retrieval of heart, liver, kidneys, and corneas was done. The QIs calculated based on the above data analysis are summarized in [Table 3]. Possible donors constituted 7.6% of deaths and PDs 4.7% of deaths in relevant ICUs. The referral rate, contraindication rate, request rate, and consent rate were 80%, 40%, 66.6%, and 50%, respectively.
|Table 3: Results of quality indicators for organ donation following neurological determination of death|
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Of 20 LAMA patients with DBI, 11 possible donors on mechanical ventilator were identified. There were five PDs with evidence of BD, of whom two were referred to ODC. There was contraindication to OD in one patient due to sepsis, while the family of the second patient decided against going donation.
| Discussion|| |
This is the first report on QA in OD from a hospital in India. Several issues on QA and outcomes in OD were addressed by this study. The OD capacity of a hospital depends on the number of possible donors. The denominator when calculating the QI for possible donors could be all deaths, deaths in all ICUs, or deaths in relevant ICUs. Majority of deaths in hospital in India take place in the ICU. Some of the ICU beds such as those for living organ donors and recipients, bone marrow transplant, coronary care, cardiothoracic surgery, and neonatal ICU may not be relevant to OD and were excluded. We also excluded pediatric ICU beds for the purpose of this audit, making only 27/87 (31%) ICU beds relevant to OD. Possible donors constituted only 7.6% of the deaths in relevant ICUs indicating that there were limited hospitalizations for patients with head trauma and stroke. A trauma center would see this figure sore to above 50%, while any hospital with a figure below 10% can expect only a few donations in a year.
Once clinical signs of BD are apparent in a possible donor, the PD is born. Less than 800 deceased donors a year in a country with 95,000 ICU beds suggests that PDs are either not identified or do not progress along the pathway of testing for BD, donor optimization, counseling, and OD. Keeping this in mind, and to make the audit more meaningful, we classified PDs into five categories. Of the 10 PDI, only eight were referred to ODC. The reasons for not referring two patients to ODC were not clear. Possible reasons can include professional reluctance on the part of ICU team, nonavailability of next of kin, or lack of keenness of treating neurologist/neurosurgeon to engage with the family due to the aggressive nature of the family or in the immediate postoperative period. Attempts at subclassification of PDs are important to pin-point the lacunae in a given clinical setting. Critical care teams must identify all PDs early. Once identified, the team should refer all such patients to ODC for assessment, irrespective of contraindications to OD. Members from ODC, especially those from hospital administration, would do well to encourage early reporting following daily rounds.
Data on PDs from all parts of the world are inconsistent due to difference in upper age limit and variation in exclusion of those with contraindication to OD. A survey of over 200,000 deaths in ICU at 140 hospitals in Spain identified 25,653 PDs, constituting 12.4% of all deaths. Expectedly, the proportion was much higher in hospitals with an active neurosurgery program. An audit from the UK on 34,235 deaths for the year 2019–2020 showed 1994 (5.8%) PDs. Contraindication to OD was seen in 4.1%. In a study from Canada on 335793 hospital deaths, 8274 (2.5%) PDs were identified. In the only previous study from India, we have shown that when prospectively monitored, BD could be demonstrated in 8.7% deaths and 45 of 161 (27.9%) deaths among neurology and neurosurgery patients. A study from Victoria, Australia, classified PDs as Type A with confirmed BD through formal testing, Type B with BD not formally diagnosed, but the patient was likely to have fulfilled criteria for BD, and Type C with potential to progress to BD within 24 h if supportive treatment, such as ventilation, had been continued. When data is submitted from hospitals in India, most off the time we are reporting PDTCs. We should encourage teams to report all PDIs, so that nation-wide estimates on PDs are available. A large study from US with 18524 PDs estimated that the number of PDs per hospital bed in a year increased with the size of hospital, being 0.015 for hospitals with more than 350 beds, 0.012 for 150–349 beds, and 0.006 in those with 149 beds or less. In our study, the estimated annual PDs were 0.370 (10/27) per bed in relevant ICUs, 0.114 (10/87) per bed in all ICUs, 0.034 (10/290) per bed for total hospital beds, or 0.028 (10/352) per death in hospital. The figure would be much higher for trauma centers and much lower for hospitals with no neurosurgery facility. Based on above estimates, we can expect 11,286 PDs from the 99,000 ICU beds in India.
The referral rate in our study was good at 80%. The contraindication rate was high at 50% of referred patients, as extremes of age were included. Once patients were tested (PDT), all had confirmation of BD (PDTC). The UK audit has also shown that once BD is suspected by ICU teams, BD was confirmed with formal testing 99% (1729 of 1743) of the times. The request rate in our study was 66.6%. A study from Kerala, India, from a 350-bedded hospital reported 41 PDs over a 2-year period and consent rate was high at 84%. Our consent rate was 50%. The most common cause of BD was CVA in our study, much like another retrospective study on 100 deceased organ donors over 23 years from a single hospital at Pune, Maharashtra.
Futility in continuing treatment or the high cost of treatment in a private hospital in a population largely not insured for health benefits could be the reasons for LAMA. We have shown that of the total of 36 possible donors, 20 (55%) proceeded LAMA, while 16 (45%) died in hospital. Hence, evaluation of the LAMA arm is important in any QA on OD in a hospital in India.
Low public awareness, sociocultural, religious, legal, and ethical factors have been cited as the main reasons for low donation rate in some parts of India.,, However, most experts now feel that it is the hospital arm which is the weak link and must be addressed on priority. Training on the process of declaration of BD, DNDD and DCDD, donor optimization and engaging with families should be a part of curriculum for ICU doctors. Creation of more transplant centers and ICU beds in state-funded institutions with lowering of cost of transplantation and medication has also been recommended.,
We have shown that retrieval of relevant data is possible by auditing the mortality records of a hospital in India. The type of information required and the possible source with pros and cons is summarized in [Table 4]. Information from death summaries was often incomplete and full medical records had to be obtained to ascertain the facts. Inclusion of GCS and all brain stem reflexes in the death summary of patients with DBI can help in improving accuracy of data collected for QA. A report on QA and outcomes on OD can be generated based on the parameters discussed, identifying the relevant areas for improvement. We recommend that this type of internal QA should be carried out once in three months and an external QA be done annually by the relevant state authority.
|Table 4: Summary of possible sources of information for audit on organ donation in a hospital|
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It is a single center study. Similar studies from multiple centers can further validate the results.
| Conclusion|| |
Retrieval of data relevant to OD is possible by auditing the available mortality and LAMA records from hospitals 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.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]