Effect of the Organ Donation Quality System on Donation Activity of Warsaw Hospitals

Introduction

Organ transplantation is a preferred method for treating end-stage organ failure. Insufficient numbers of organ donors and an ever-increasing number of wait-listed recipients fuel universal organ scarcity [1–5]. The organ shortage problem is further magnified by non-identification of potential donors, aging of the population, and increased incidence of lifestyle diseases such as hypertension, obesity, and diabetes, as well as objections to donation.

To address the organ shortage and differences in donation rates among various countries, the member states of the European Union implemented a donation quality improvement program called the Organ Donation European Quality System (ODEQUS) [6,7]. Numerous procedures, criteria, and quality indicators of organ donation process were designed and set within the framework of this practice-based system. These defined sets of quality indicators and determined methods of result measurement strategy put into action allow for an overview of the efficiency of transplantation systems at regional and national levels [8,9]. Legally, identification of deceased organ donors can only be carried out in hospitals equipped with facilities and staff capable of diagnosing brain death, with appropriate donor care (intensive care unit), and equipped to handle the retrieval of multiple organs (operating theater). To increase donation activity, Poland has implemented several fundamental programs, including expansion of the in-hospital organ donation coordinator network, a system of postgraduate education for transplant coordinators, participating in the European Training Program on Organ Donation (ETPOD), online monitoring system for organ donation (the koordynator.net webtool), and a hospital-level system for quality of organ and tissue donation from deceased donors [4,10]. Programs based on retrospective studies and death audits proved ineffective. Despite being able to aid in detection of brain death non-identification events, they do not prevent loss of potential donors – auditing is not done in real time but analyzes closed cases and events [4,11]. Quality procedures precisely describe the main steps of organ donation to secure smooth conduct of the process and to reduce errors [2,6]. Some hospitals have implemented procedures for potential donor identification, brain death diagnosis, donor care, authorization of donation (including taking to donor’s family), coordination of organ retrieval, and cooperation with the transplant center and the Poltransplant, as well as education and audits. These procedures were shown to result in higher rates of organ donations from deceased donors [12].

The aim of this study was to compare the potential of organ donation in Warsaw hospitals that did or did not implement donation quality procedures in 2017–2018 (prior to the COVID-19 pandemic).

Material and Methods

Fifteen institutions in Warsaw met organizational and legal criteria for organ donation potential. We divided them into 2 groups: hospitals with established organ donation quality procedures (QUALY+, n=4) and hospitals without such procedures (QUALY−, n=11). Hospitals with strict oncological or pediatric profiles were excluded from the study. The groups did not differ in terms of service characteristics, including ICU reference level and the presence of neurology/neurosurgery departments (Table 1).

Data on the actual number of beds, total number of admissions, in-hospital deaths, and deaths with specific ICD10 codes [6] suggestive of severe brain injury (trauma, cerebrovascular accidents, cerebral damage, cerebral neoplasm, CNS infections), as well as the number of potential and effective donors, were retrieved from the National Health Fund (NHF), National Transplant Registry, the Registry of Healthcare Providers (RPWDL) databases, Warsaw hospitals, and the web-based platform for reporting coordinators’ activity (http://koordynator.net). A retrospective analysis of hospitalizations and deaths was conducted using indicators for assessing the potential for organ donation from deceased donors and rates of program efficiency [10]. The actual donation activity of a hospital was calculated according to the methodologies of the “Improving the Knowledge and Practices in Organ Donation” (DOPKI) European Commission project and the Organ Donation European Quality System (ODEQUS) program [3,4]. Both hospital-scale and ICU-scale indices applicable to deceased donor detection and organ donation were calculated in QUALY+ and QUALY− groups. The percentage of multiorgan donors and the reasons for donor loss were addressed.

The results are presented alongside the DOPKI and ODEQUS data [7]. Quantitative variables are described as mean (M) and standard deviation (SD) or median (Mdn) with the first and third quartile (interquartile range, IQR). The normality of distribution of continuous variables was tested using the Shapiro-Wilk test. To compare the study groups, Student t-test, Mann-Whitney U test, or chi-square test were applied as appropriate. A p-value of <0.05 was considered significant. The analysis was performed using STATA 13 Statistical Software.

Results

In 2017–2018, a total of 273 776 patients were treated in 4 QUALY+ and 394 593 (59%) in 11 QUALY− hospitals located in Warsaw. Mortality rate was lower in QUALY+ hospitals (2.53% vs 3.17%, p<.001) and 64.4% of all fatalities occurred in QUALY− hospitals. Despite higher mortality and number of deaths, significantly fewer brain deaths were reported in hospitals from the QUALY− group (0.2 vs 1.2% of all hospital deaths and 1.1 vs 5.3% of ICU fatalities, p<.003, see Tables 2, 3).

The results obtained in Warsaw hospitals differed significantly from those found in DOPKI and ODEQUS projects.

Over 50% of effective organ donors were multiorgan donors. In the group of hospitals with implemented quality procedures, the percentage of multiorgan retrievals was almost 7% higher than in the group of hospitals without procedures (52.33% vs 45.46%), and it was statistically significant p=.017.

The study demonstrated that all 15 Warsaw hospitals had donation potential estimates very divergent from the DOPKI and ODEQUS projects. Only medical disqualification rate and conversion of potential to effective donor were similar. QUALY+ hospitals achieved higher rates of donation potential than hospitals without any quality procedures. However, the results in most hospitals remained lower than the DOPKI and ODEQUS results.

Discussion

Donation activity and identification of potential donors in Mazovian hospitals were low and utterly unsatisfactory. This was demonstrated with every indicator used for measurement. Even in QUALY+ hospitals, the brain death (DBD) to hospital beds ratio was less than 50% of that shown in the DOPKI study (1.77% vs 3.9%). Nevertheless, it was 5 times higher than in hospitals without quality procedures (0.31%). The proportion of diagnosed brain deaths to the number of hospitalizations (hospital admissions) was 5 times lower than in DOPKI project (0.016% vs 0.08%), 13 times if the hospitals did not implement quality procedures (0.006%). Number of brain deaths per ICU bed per year was 4.5 times lower than shown with DOPKI (52.44 vs 109.2). Again, QUALY+ hospitals did a lot better than QUALY− (52.44 vs 7.91). The proportion of brain deaths (BD) to the total number of hospital deaths in both groups was 5 times lower than in DOPKI analysis (0.55% vs 2.9%). QUALY+ hospitals performed much better than QUALY− ones (1.24 vs 0.18%). On the other hand, the rate of a BD who achieved an effective organ donor status in Warsaw hospitals was 30% higher than in the DOPKI program (72.22% vs 42%). The percentage of medically unsuitable donors in ODEQUS program was comparable to our study. This all confirms our previous findings, that BD is severely underdiagnosed in Polish hospitals, especially if they did not implement any donation quality system. The extreme conversion rate raises suspicion that brain death is only diagnosed when organ donation is considered. Lack of potential donor identification is one of the main reasons for organ donor loss [11]. Expertise in identification and diagnosis of brain death is essential for an efficiently working organ donation system [13,14]. Checkpoints of the process are active monitoring of patients with brain injury (based on ICD-10 diagnosis) and timing of the referral to a transplant coordinator with critical role of an ICU staff [2,15]. The ICU is an optimal setting for diagnosis of brain death and appropriate medical care in terms of refurbishing circulatory homeostasis [16]. Our research showed that in Warsaw hospitals, 70% of deaths with selected ICD-10 codes related to severe brain injury occurred outside of ICUs. Of 1277 deaths with these ICD-10 codes, hospitals with an organ donation quality system had significantly more brain deaths than hospitals without such a system (12.04% vs 3.91%). Each hospital should perform systematic analysis of donation potential, with careful assessment of every death from a selected ICD-10 for the possibility of organ donation [1,17]. An up-to-date registry of medical records of all comatose patients (GCS ≤8 points) increases the number of identified brain-dead patients [10,17].

Systematic analysis of causes of non-donation and disqualifying specific organs allows minimization of loses. Implementation of organ donation quality results in a lower rate of objections to donate [14,18]. In Poland, a presumed consent system (opting-out system) is in effect. We recorded 17 objections to donate expressed by the immediate family as “living person will.” None of them were found in the formal national Central Registry of Objections, which implies unawareness of the Registry and legal regulations in lay society. According to ODEQUS, the refusal rate should be lower than 10% [8], and in our study in Warsaw hospitals it was 15%. When no quality procedures were in place, the refusal rate exceeded 20%. Inexperience and inadequate communication skills could have been responsible.

The conversion rate (the number of potential organ donors without medical contraindications to donation divided by the number of refusals [10,19,20]) should be 75% according to ODEQUS. In our study, the conversion rate for all hospitals was 82%. In the group of hospitals with procedures, this rate was significantly higher than in hospitals where procedures were not implemented (84% vs 75%).

The key person in the organ donation program is the transplant coordinator. Each QUALY+ hospital employed a transplant coordinator. Only 6 of 11 facilities without quality procedures were properly staffed.

Conclusions

The conducted comparative analysis of data compiled from Warsaw hospitals and data from the international program DOPKI and ODEQUS project quality indicators showed that organ donation rates in hospitals that implemented pro-active identification and management protocols of potential organ donors achieved higher results than hospitals without such protocols.