Quality metrics in solid organ donation: A narrative review

Abstract

Evidence is not homogeneous on indicators able to monitor and assess quality performance for organ donation. This may be related to differences in healthcare organizations among countries but also to the scarcity of data on this topic so far. In the present review, we assessed available evidence on quality metrics in solid organ procurement in the United States and in Europe by means of a PubMed search. Evidence was summarized according to countries, considering that the donation and transplantation systems differ from country to country. In United States, the assessment of these indicators is periodically performed by the national network for organ sharing to evaluate the performance of each Organ Procurement Organization (OPO). Quality metrics consider several factors, in primis population characteristics (i.e. race/ethnicity, age, socio-economic status). That is why the assessment of each OPO performance relies on several quality metrics, not only one single indicator. In Europe, quality improvement programs represent a structural element of organ and transplant system in several countries, but few papers have to date addressed the results obtained by a quality improvement program based on indicators. In Poland, the use of quality indicators and improvement procedures were associated with better results in those hospitals which implemented these programs in respect to hospitals who did not. In Tuscany Region (Italy) the implementation of a monitoring and reporting approach based on indicators by the Regional Transplant Center was associated with an increased in transplant and donation activity (especially in cDCD donors). According to available evidence, the development of a method for quality assessment and quality improvement has been recognized as pivotal for donation and transplant authorities to identify key interventions either at national and/or hospital levels.

Key Words: Organ donation; Quality indicators; Quality improvement; Donor after brain death; Donor after cardiocirculatory death; Transplant activity

Core Tip: Organ donation and transplantation systems are known as complex health care systems since they involved several professionals often in time-dependent processes. The development of a method for quality assessment and quality improvement has been recognized as pivotal for donation and transplant authorities to identify key interventions either at national and/or hospital levels.

INTRODUCTION

The Council of Europe in the “Draft Council conclusions on enhancing organ donation and transplantation”[1] and in the 2009-2015 EU Action Plan on Organ Donation and Transplantation, outlined improving quality and safety as one of the three main challenges (together with enhancing the efficiency and accessibility of transplantation systems and increasing organ availability) in organ donation. Promoting quality improvement programs was one of the key measures.

Evidence is not homogeneous on indicators concerning solid organ donation, being able to monitor and assess quality performance for transplant coordinators. This may be related to differences in healthcare organizations among countries but also to the scarcity of data so far on this topic.

In the present review, we assessed available evidence on quality metrics in solid organ procurement in the United States of America and in Europe by means of a PubMed search for “quality metrics/indicators and solid organ donation/procurement and/or donor” (only in the English language). Papers were summarized according to countries, considering that healthcare organization varies between countries and, consequently, results can be translated with caution from country to country. Papers addressing quality metrics in solid organ transplantation were not included[2]. Fifty five papers were retrieved, but, after excluding papers concerning transplant activity, twenty-four papers were considered.

Process and quality measurements are well established in other spheres of healthcare delivery being associated with improvements, so it may be reasonable to assume that measurement, reporting, and assessment of organ donation and transplant processes could lead to improved outcomes.

Quality metrics are recognized as a hot topic in donation and transplantation medicine. To date, there is a lack of well-designed studies on hospital-level metrics and interventions associated with organ donation, as reported in the recent review by Castillo-Angeles et al[3], including 72 articles, among 2177 yielded studies. Most investigations showed considerable risk of bias and were of low quality and heterogeneous. Most of the interventional investigations were hospital-level, though they led to local improvements. Castillo-Angeles et al[3] concluded that there is an emergent concept in solid organ donation and transplantation organization: A central (national and/or regional) organization framework.

In the present narrative review, we summarized available evidence according to countries, considering that the donation and transplantation systems differ from country to country.

QUALITY METRICS IN ORGAN DONATION- UNITED STATES

Investigations performed on quality metrics in organ donation in the United States are depicted in Table 1.

Table 1 Evidence on quality metrics in organ donation - United States.

Ref.	Year	Country	Main results	Limitations/characteritics
Niroomand et al[4]	2020	United States	(2011-2014) an OPO’s ranking relative to other OPOs was static. Leadership changes increase the odd of rapid improvement	Study limitations: Changes in other executive team members were not assessed. OPO-level data on change in practice were not available
DeRoos et al[5]	2020	United States	The performance of OPOs was positively associated with the use of donors who were ineligible, which varied among OPOs and demographic subgroups	Quality indicator limitation (in put data). Donor ineligibility is dependent on OPOs. Therefore the analysis is restricted to OPO level
Goldberg et al[7]	2020	United States	43 states (48 OPOs) had data from 2012 to 2014 available for analysis: The CMS metric and the ventilation-adjusted CMS metric were highly concordant in absolute terms	Methodological investigation: Comparison between indicators
Doby et al[6]	2021	United States	CALC methods: Donor increased by 44%, organs transplanted rose by 29%	Quality indicator limitation: CALC datasets are based on death certificate data. No information on suitability
Lopez et al[9]	2023	United States	Cross sectional study: 58 OPOs (2028-2020). Adjusting for area deprivation and age significantly changed OPO measured performance and tier classifications	Quality indicator limitation (dependance of input data). Discrepancies in performance among areas

OPO: Organ procurement organization; CALC: Cause, age and location consistent; CMS: Centers for Medicare & Medicaid Services.

The relation between leadership change and Organ Procurement Organization (OPO) improvement assessed by objective metrics was assessed by Niroomand et al[4] by evaluating United Network for Organ Sharing and Centres for Disease Control and Prevention data (2011-2014) and measured donation rates based on location of death. It was documented that, during the 4-year study period, the OPO’s ranking relative to other OPO’s was static, but leadership change increased the odd of improvement, though not guaranteeing it.

OPO performance improvement strategies use multiple measurements to identify opportunities to target and trial operational interventions. The relevance of metrics was reported in a national study of 75769 organ donors[5]. A significant variability in OPO performance ranking was documented being related to which donation metric was used. These differences in OPO performance remained even after accounting for differences in population characteristics and significant variation in the use of ineligible donors were also observed. The authors concluded that a range of donation metrics (not a single metric) should be used to assess the OPO performance. In a single OPO[6] an improvement initiative was implemented using the cause, age and location consistent (CALC) method[7] (cause, age, and location consistent) to identify opportunities for improvement. CALC data let the OPO to effectively benchmark donor conversion by age and race/ethnicity. This allowed the formulation of an intervention plan, including strategies to reexamine practice (including referral screening). An increase in organ donors of 44% was reported together with an increase of 29% in transplanted organs for the 12-month period ending September 30, 2020, because of targeted practice changes. The main limitation of the CALC methodology is that it relies on death certificates, acknowledged to be fraught with errors[8].

The role of population characteristics in affecting donation and transplant rates was reported in a cross-sectional study of population characteristics and OPO performance metrics in 58 OPAs from 2018 to 2020[9]. The rationale of this investigation relies on the hypothesis that performance metrics should be adjusted for social risk factors. Higher neighborhood disadvantage, lower socioeconomic level, and lower educational attainment were found to be associated with lower organ donor registration and authorization rates donor consent rates and age were associated with rate of donation. The Authors documented that OPA measured performance and classifications significantly changed after adjusting for area deprivation and age. These findings suggest that donation and transplant rates are influenced by underlying population characteristics, independently of OPO performance. In this context, analyzing Organ Procurement and Transplantation Network data of all deceased donors from January 1, 2009 to December 31, 2018, it was documented that increased number of donors observed on national-based should be attributable to the drug epidemic and not to an improved system[10].

Evidence regarding quality metrics in organ donation in OPOs documents that the assessment of these indicators is periodically performed by the national network for organ sharing (The United Network for Organ Sharing) to evaluate the performance of each OPO. Quality metrics should also consider several factors, in primis population characteristics (i.e. race/ethnicity, age, socio-economic status). That is why the assessment of each OPO performance should rely on several quality metrics, not only one single indicator.

QUALITY METRICS IN ORGAN DONATION- EUROPE

The Organ Donation European quality system (ODEQUS) was a three-year project (October 2010-December 2013), co-financed by the European Agency for Health and Consumers, aimed to define a method to assess the organ procurement performance at hospital level. Quality criteria (QC) and quality indicators (QI) were developed in three types of donors: After Brain Death, after Cardiac Death and Living Donation. Three were the main fields considered: Organizational structures, clinical procedures and outcomes. One-hundred and thirty-one QC and thirty-one QI were identified and tested in 12 European hospitals by means of internal and externa validation[11]. Two types of training[12] were designed and performed: One concerning the development of quality criteria and quality indicators, whereas another was focused on how to use evaluation tools. Following participation in the ODEQUS project, a quality system was created at the hospital level in Warsaw[13] (Table 2).

Table 2 Evidence on quality metrics in organ donation - Europe.

Ref.	Year	Country	Main results	Limitations/characteritics
Manyalich et al[11]	2013	Consortium: Austria, Croatia, France, Germany, Italy, Poland, Portugal, Romania, Spain, Sweden, and the United Kingdom, as well as five collaborating partners from Greece, Hungary, Malta, Slovenia, and Turkey	131 quality criteria and 31 quality indicators	Methodological issues
Karpeta et al[19]	2024	Warsaw (Poland)	Hospitals with implementing procedures had significantly higher values than hospitals without	Critical analysis of quality assessment in donation activity
Lazzeri et al[25]	2025	Tuscany Region (Italy)	From January to November 2024, 352 donors (2024 January-November): Donation activity comparable 2024 vs in 2023 (101.2 vs 103 pmp). Controlled DCD increased (+13). Transplant activity: Increased (2024: 91.3 pmp vs 2023: 80 pmp)	A method for buidling a quality assessment system. This reporting system was suited to the Tuscany Region. However, the methodology of implementing this system may be trasferred to other donation and transplantation systems

pmp: Per milion population; DCD: Donation after circulatory death.

In Belgium in 2016 a study was conducted over a 4-month period[14] to identify and select a set of relevant key interventions and quality indicators to develop a specific care pathway for donation after brain death and to rigorously evaluate its impact. Eleven quality indicators were identified for the management of a potential donor after brain death by a multidisciplinary panel of 18 Belgian experts by means of a three Delphi rounds). Sixty-five key interventions were identified and considered, together with quality indicators, to be applicable in quality improvement programs for donors after brain death. In 2018 the Italian National Center reported quality indicators in the National Program for Organ donation (2018-2020) for brain death donors[15]. The aim was to provide transplant coordinators a tool (that is quality indicators) to track DBD activity and to make DBD activity more homogeneous among Italian Regions.

A conceptual framework for evaluating national organ donation and transplantation[16] was constructed based on a targeted review of the relevant medical literature. These frameworks are recognized as useful for complex heath care systems since they represent a method able to synthetically consider several factors contributing to implementation and outcomes. In the organ donation and transplantation framework[17] sixteen essential domains were identified as critical for initiating and maintaining a successful program. Quality standard and quality improvement was one of these areas (included among the structural elements). According to this conceptual framework, organ donation and transplantation systems in some European countries were described.

Recent evidence introduced conceptual frameworks in assessing donation and transplantation health care system and reported that an accurate system-wide analysis is needed to assess performance and to identify areas in need of improvement[17-21].

In Portugal[22] quality standard and continuity quality improvement were one of the structural elements considered for building a sustainable and effective national organ donation and transplantation system. Several steps and achievements were performed in Portugal since 1993, to build a sustainable and effective organ donation and transplantation program. A multi-functional information technology platform was implemented by the Portuguese transplant authorities to support clinical pathways associated with organ donation and transplantation. This platform also helps authorities to track activities and represents a tool to support quality improvement and biovigilance. Details on the type of quality indicators and metrics were not provided in the paper[16], mainly because its aim was to describe structural changes in the Portuguese transplant authority that led to an improvement in donation (33.3 deceased donors per million population before coronavirus disease pandemic).

In the United Kingdom organ donation and transplantation program, the National Health Service Blood and Transplant (NHSBT) databases provide data on potential donations and the reasons for which potential donors do not become actual. The NHSBT publishes annual national reports and benchmarking data. This information proves to crucial in increasing the number of donations in the United Kingdom[23].

The National organ donation and transplantation program in Greece monitor a few quality indicators which are included in annual reports, but no quality standards are provided to guide donation, pre-transplant, or post-transplant care[24].

Few papers address the implementation and the results obtained by a quality improvement program based on indicators in Europe. In a retrospective analysis performed in Poland[25] the organ donation potential in Warsaw hospitals was assessed comparing hospitals with implemented donation procedures with those without in the years 2017–2018. Interestingly the obtained results were compared with quality indicators established in the ODEQUS project and the European Commission project “Improving Knowledge and Practices in Organ Donation” (DOPKI).

We recently described the reporting and monitoring approach for the assessment of quality performance implemented in 2022 by the Tuscany Procurement and Transplant Center [Organizzazione Toscana Trapianti (OTT)][25]. The Tuscany Region (Italy) has a high annual number of donors (about 100 pmp), that is the highest rate among Italian Regions and many European countries[26]. Since 2021, a reporting and monitoring system for quality performance management has been introduced by OTT for procurement and transplant activities. This goal of this approach was to maintain the high procurement activity of the Tuscany Region while improving transplant activity. This reporting and monitoring approach was based on indicators which were either modified in respect to those reported by the ODEQUS project and/or newly introduced[11,12,23]. The monitoring and reporting system introduced by OTT was based on the following principles: (1) Indicators are not themselves goals or punitive for the system. This essential concept was communicated to transplant coordinators and transplant centers; and (2) Indicators should be measurable, feasible, relevant, and reliable. Our reporting and monitoring approach can be briefly summed up as follows: (1) Identifying indicators clinically relevant for donation and transplant activities; (2) Adopting a systematic double-check approach. Our report is periodically double checking our data with the database by the National Transplant Center and that by the Management and Health Laboratory in Pisa. The main strength of this “double-checking procedure” is that all these three reporting systems have different sources of data. In details: The National Transplant Center stems data from the Transplant Informative System (Sistema Informativo Trapianti) while the Management and Health Laboratory in Pisa from ICD code; (3) Elaborating reports which are transmitted, at least monthly, to hospital management staff, transplant coordinators, and transplant centers, and (4) Discussing, at least twice a year (and/or when needed), with the management staff and transplant coordinators or transplant centers to identify specific areas of improvements, locally tailored. Our reporting and monitoring approach led to the maintenance of a high donation activity (about 100 donors per million population) and an increase in transplant activity (91.3 pmp in 2024 vs 80 pmp in 2023) in Tuscany. This approach was shown to be effective and efficacious for the solid-organ donation and transplant system in Tuscany.

The recent Guide to the quality and safety of ORGANS FOR TRANSPLANTATION 9^th edition[27] reported DOPKI and ODEQUS indicators. A comparison between the top ten organ donor countries with four countries in the South East Asia concerning health system impact on deceased organ donation was recently published[28]. Many variables related to healthcare systems but no mention to quality indicators for organ donation activity, also considering that not all countries have registries.

According to available evidence, each existing quality indicator has shortcomings which may influence the reliability of indicators themselves. For instance, the CALC method is dependent on death certificates. In our opinion, shortcomings of indicators may be overcome by three factors: (1) Systematic and periodical checking of input data by donation and transplant systems; (2) The regular double checking of input data/indicators with other quality systems (i.e. regional vs national); and (3) The use of clusters of indicators to overcome the shortcomings of each of them and to gain a clinical information and/or identify an area of improvement.

CONCLUSION

Organ donation and transplantation systems are known as complex health care systems since they involved several professionials often in time-dependent processes. Conceptual frameworks, recently developed, represent a holistic view of the entire system which can help traonsplant authorities to assess healthcare system performance and quality and to assist in their planning and development. Quality improvement has been recognized as one of the structural elements of each donation and transplantation system. The development of a method for quality assessment and quality improvement has been recognized as pivotal for donation and transplant authorities to identify key interventions either at national and/or hospital levels. The goals of quaity improvement methodology are mainly to improve donation activity and to guarantee safety in donation processes and make donations actvity homogeneous among centers. The present review documents that evidence on this topic is not uniform among countries, even if increasing in the recent years. The role of a central governance and the importance of implementing a quality improvement program are widely recognized as crucial for a donation and transplant authority. The quality improvement program relies on indicators which have been identified and proposed in previous projects[11-13,16] but not extensively implemented. Nowadays donation processes are quite complex due to several contributing factors, from technical issues [i.e. normothermic regional perfusion (NRP) implantation, use of ex vivo perfusion], clinical ones (donors with advanced age and comorbidities) to organizational ones (i.e. NRP mobile teams, donations in other European countries). In this context, quality improvement programs do represent a useful, pivotal for an efficacious and efficient clinical governance of organ donation and transplant systems. In our opinion, further research is needed to identify few quality indicators for donation activity (that is a cluster of two or three indicators) to be implemented on an international scale. Similarly, clusters of indicators should be identified and implemented systematically on a national level. Thus, donation activity could be compared among countries, and moreover, the identification of areas for improvement (on an international and/or national scale) would be more easily performed, based on objective data.