Open access Original research Implementation of a quality management system in a liver transplant programme Yolanda López-­Púa ‍ ‍,1 Miquel Navasa,2 Antoni Trilla,3 Jordi Colmenero,4 Raquel García,2 Eva López,2 Anna Durà,2 Ana Guash,2 José Ríos5 To cite: López-­Púa Y, Navasa M, ABSTRACT Trilla A, et al. Implementation WHAT IS ALREADY KNOWN ON THIS TOPIC Background The management of liver transplantation of a quality management ⇒ Government health policies encourage and promote has become a complex process involving different system in a liver transplant the provision of comprehensive healthcare with high healthcare professionals. Teamwork, standardisation and programme. BMJ Open Quality levels of quality, as well as the implementation of 2023;12:e002440. doi:10.1136/ definition of the best practices are essential for success, patient satisfaction and society’s favourable perception of quality management systems (QMS) to ensure that bmjoq-2023-002440 transplantation programmes. patient care and the processes involved are efficient ► Additional supplemental ISO 9001:2015 certification provides the necessary and with maximum guarantees of clinical safety. material is published online only. elements to help implement a quality management To view, please visit the journal WHAT THIS STUDY ADDS system (QMS) to ensure that patient care is performed online (http://​dx.​doi.​org/​10.​ with the highest guarantees of clinical quality and safety. ⇒ It provides a practical insight into the experience 1136/​bmjoq-​2023-​002440). of implementing a QMS in a liver transplantation The aim of this study is to describe the steps, strengths and limitations in the implementation of a QMS in a liver programme. Received 2 June 2023 transplant programme (LTP). HOW THIS STUDY MIGHT AFFECT RESEARCH, Accepted 7 September 2023 Project management method This included PRACTICE OR POLICY analysing the starting point, setting up a working group, ⇒ By encouraging liver transplant units to implement training, defining the scope of certification, preparing documentation, and conducting an internal and external a useful QMS with the aim of promoting quality and audit, which culminated in the ISO 9001 quality safety in patient care, and establishing the standard © Author(s) (or their certification award. The scope of QMS includes all the requirements for liver transplant units. employer(s)) 2023. Re-­use processes of LTP, from referral of candidates to long-­term permitted under CC BY-­NC. No follow-­up after transplantation. commercial re-­use. See rights Results The project was structured in seven phases that and permissions. Published by demanding of healthcare services.1 2 The BMJ. took place between 2008 and 2011. The implementation WHO,3 4 the guidelines set by the European 1 Quality Unit, Biomedical of QMS led to the generation of all the necessary documentation to meet the requirements of the standard, Union5 and Spanish legislation6 7 emphasise Diagnostic Center, Hospital Clinic de Barcelona, Barcelona, including internal and legal requirements related to the the provision of comprehensive healthcare Catalunya, Spain transplant activity. The establishment of indicators to by ensuring high levels of quality and the 2 Liver Transplant Unit, Hospital measure the effectiveness of processes, risk management implementation of quality systems that are Clinic de Barcelona, University and the identification of incidents allows us to implement evaluated by independent bodies. As a conse- of Barcelona, Barcelona, measures devoted to avoiding the deficiencies and to meet quence of the application of these policies, Catalunya, Spain the established objectives. 3 Preventive Medicine Unit, the implementation of a quality manage- Conclusion ISO 9001:2015 certification has contributed ment system (QMS) in clinical units has been Hospital Clinic de Barcelona, to the adaptation of a new quality and safety culture University of Barcelona, increased in recent years with the aim of Barcelona, Catalunya, Spain focused on the patient. All activities are protocolised, ensuring that patient care and the processes 4 Liver Unit, Hospital Clinic de everything is recorded, measured, and verified, and all steps are taken as planned. Work is carried out in terms of involved are efficient and have the greatest Barcelona. IDIBAPS, CIBERehd, University of Barcelona, continuous improvement. This has led to less variability in guarantees of quality and clinical safety. Barcelona, Catalunya, Spain daily clinical practice and a better understanding of work ISO 9001,Quality Management Systems 5 Department of Clinical dynamics. Requirements,8 is the global reference for Farmacology, Hospital Clinic de QMS adopted by millions of organisations Barcelona, Hospital Clinic and worldwide, providing the criteria for a QMS Medical Statistics Core Facility, IDIBAPS. Biostatistics Unit, INTRODUCTION supported by a process model and the PDCA School of Medicine, Universitat The effectiveness of the quality and safety of (Plan-­Do-­Check-­Act) cycle to achieve desired Autònoma de Barcelona, healthcare processes, as well as the satisfac- outcomes and customer satisfaction. The Barcelona, Catalunya, Spain tion of patients and professionals involved, first ISO 9001 international standard was Correspondence to continues to arouse growing interest from issued in 1987 and reviewed in 1994 to clarify Yolanda López-­Púa; healthcare organisations and institutions, and preventive and mandatory documentation ​yolopez@​clinic.​cat in general, from a society that is increasingly requirements. López-­Púa Y, et al. BMJ Open Quality 2023;12:e002440. doi:10.1136/bmjoq-2023-002440 1 Open access The following ISO 9001 edition was issued in 2000, on providing a useful tool for professionals. With this adopting the process approach, and was subject to a mild approach, it was essential to homogenise care practices revision in 2008 to clarify certain requirements. Finally, and clinical criteria so that the care offered to the patient in 2015 the present version of ISO 9001 was published, would be carried out in the same way, with all the guar- emphasising the need to monitor the context and eval- antees of quality and safety, regardless of the professional uate the stakeholders that influence the organisation attending the patient. and the process approach with more flexibility and less It was also intended that the QMS would help to retain focus on documentation.9–11 Implemented QMS Stan- the clinical care knowledge acquired over the years by the dards such as ISO 9001 can be audited and certified by most senior professionals. For this reason, the QMS orien- independent third-­party organisations (the certification tation was intended to be entirely clinical. The major body) to assess if the QMS complies with the applicable challenge and complication of the project was mainly requirements and if the intended results are achieved.11 adapting the complex activity of liver transplantation to a The implementation of a QMS in accordance with ISO non-­specific standard outside the clinical setting without 9001:2015 involves the establishment of an organisational losing its clinical care orientation. The team responsible structure, the integration of responsibilities, definition of for planning and developing the project consisted of processes, protocolisation and standardisation of activi- the following professionals: the head of the liver trans- ties, and ensures that processes are properly resourced plant unit, an external quality manager, hepatologists, and managed.12 The objective is to provide tools that help surgeons, anaesthesiologists, an intensive care and ward organisations to achieve better results through the appli- nurse coordinator, an outpatient and anaesthesia nurse, cation of continuous improvement, ensuring compli- and administrative staff. All of them received training in ance with the customer and conformity with regulatory the ISO 9001 standard. requirements. Consequently, the focus is on increasing A quality committee was also set up to monitor the the efficiency of the processes, preventing deficiencies, QMS, and its composition and functions were defined, as and seeking a benefit for the patient.13 14 well as the frequency of meetings. The liver transplant programme (LTP) of the Liver Seven project phases were identified and planned Transplant Unit from the Institute of Digestive and Meta- (figure 1). bolic Diseases at Hospital Clinic, Barcelona, has been a benchmark programme since its creation in 1988, both First phase: Analysis of the starting point for the number of transplants carried out to date (2460) The status of the programme was analysed in terms of and for the excellent short-­term and long-­term results compliance with the requirements of ISO 9001. This anal- obtained. The probability of patient survival is 94% in the ysis focused on the process approach, the documentation first year and 80% in the fifth year. required, continuous improvement through the analysis The programme was certified according to the inter- of results and the implementation of adequate meas- national ISO 9001 standard in 2011 and according to the ures, the recording and resolving of incidents and non-­ Spanish UNE 179008, the QMS for liver transplantation conformities, the assessment of customer satisfaction, units, standard15 in 2017. management responsibilities, competencies and training The aim of this paper was to describe the design, imple- of professionals, the maintenance of facilities and equip- mentation and certification process of a QMS in an LTP ment involved in processes, and the implementation of and to explore its applicability and usefulness in a liver corrective actions. transplant unit. Second phase: Establishment of the working group A multidisciplinary working group was created to plan PROJECT MANAGEMENT METHOD and develop the project, composed of hepatologists, The process of adaptation to the ISO 9001 standard surgeons, nurses and administrative staff. started in November 2008. Two fundamental aspects were considered for the planning and implementation of the Third phase: Training QMS in the LTP. The main premise was that the QMS The team responsible for the project was trained in the should be applied to all medical interventions performed requirements of the ISO 9001 standard. by the programme, regardless of whether the patient was a potential transplant candidate, a transplant candidate Fourth phase: Scope of certification on the waiting list or a patient who had a transplant. The To establish the scope of the QMS in a coherent manner, second premise was that the system should be focused all the processes involved in liver transplant were mapped Figure 1 Project phases. 2 López-­Púa Y, et al. BMJ Open Quality 2023;12:e002440. doi:10.1136/bmjoq-2023-002440 Open access out with the help of all the professionals involved in the dependent on the AEN/CTN 179 committee ‘Quality transplant process. and safety in healthcare centres’. The project had a high level of participation of public Fifth phase: Creating and updating documentation and institutions, including the Spanish Ministry of Health, implementation of the QMS Transplant Coordination of the Spanish autonomous A standard operating procedure for the control of docu- communities, the National Federation of Liver Patients mentation and control of records was created to establish and Transplant Recipients, the National Transplant Orga- the bases for the documentation format, content layout, nization, the Spanish Society of Liver Transplantation, coding, drafting, review and approval, identification of and more than 10 Spanish university hospitals. As a result changes, distribution of current versions, and manage- of this work, the UNE 179008 standard was elaborated. ment of obsolete documents. The implementation of the QMS was carried out simul- taneously with the elaboration of the documentation. RESULTS First phase: Analysis of the starting point Sixth phase: Conducting the internal audit At the starting point, there were many documents, An internal audit was carried out to determine the degree protocols and policies describing the tasks involved in of adherence of the QMS to the ISO 9001 standard and the LTP, as well as indicators of the performance of the to internal, legal and regulatory requirements. Non-­ programme. However, in most cases these documents did conformities, observations and opportunities for improve- not comply with all the requirements of the ISO 9001 ment were detected and corrected. standard. Seventh phase: Conducting the certification audit The certification body was chosen, and the certification Second phase: Establishment of the working group audit was carried out. The working group was established, as shown above in the Data relating to customer satisfaction, results of audits, Project management method section. indicators, the relationship with internal suppliers, and the effectiveness of actions proposed to address non-­ Third phase: Training conformities and reduce risks are reviewed and analysed The working group received training from an external quarterly in order to assure the compliance with the QMS quality manager. In addition, this person was always and to monitor the continuous improvement. present during the development of the project. After the implementation and evolution of our QMS, we wanted to go to a step further and to promote the Fourth phase: Scope of certification development of a specific standard for liver transplant The scope of the QMS was defined, and the process map units in Spain. was drawn up. The process map allowed us to visualise We proposed this project to the Spanish Association for the relationships between the different types of processes Standardisation and Certification (AENOR) and it was defined: strategic processes, focused on the fulfilment of successfully approved. AENOR established the working our policy, mission and objectives, key processes, directly group AEN/CTN 179/GT12 ‘Liver transplantation’, related to the patient, and support processes, necessary Process Map - Liver Transplant Program Strategic planning Continuous Patient data Quality External Transfer to Teaching Research Data Logging training management Management relations industry Outpatients / Operating room Intensive care Hospital ward Outpatients Cadaveric donor search Hospitalisation unit Waiting list immediate notification *OCATT Post-surgery Complications Post-transplant First Medical visit management and assessment care management follow-up Patients / Donors Patients / Donors Pretransplant Study Operating room Complications Long-term (surgery) Cures management follow-up Decision Transplant Coordination Planned intervention Readmissions Living donor search Study and Approval Post surgery Cures Follow-up evaluation Other infectious Computer Social medical Anaesthesiologists Laboratories Endoscopy Haemotherapy OCATT Psychiatry Radiology Rehabilitation diseases systems work specialities Environmental Billing Waste Human resources Occupational Information Clinical quality Archive Cleaning Maintenance and safety control department management management risk prevention systems management Strategic processes Key processes External key processes Supporting processes *OCATT: Catalan Transplantation Organisation Figure 2 Process map. López-­Púa Y, et al. BMJ Open Quality 2023;12:e002440. doi:10.1136/bmjoq-2023-002440 3 Open access to carry out the activity. The processes defined are shown Sixth phase: Conducting the internal audit in figure 2. When the QMS was implemented, an internal audit was carried out to determine the degree of adherence Fifth phase: Creating and updating documentation and to the standard. It was necessary to correct four non-­ implementation of the QMS conformities for improvement. After 3 months, the certi- Documentation was generated to meet the requirements fication body was chosen, and the external certification of the standard, the internal and legal requirements audit was carried out. related to transplant activity. The quality policy, quality manual, organisational chart, job descriptions and quality Seventh phase: Conducting the certification audit objectives were elaborated. After the correction of the non-­conformities detected, Twenty-­three general procedures related to processes the certificate of compliance was obtained in August were created, 13 of which were medical, nursing or 2011. Since the implementation of the QMS, the quality administrative procedures related to the evaluation of committee has met quarterly to review process perfor- transplant candidates, assistance in hospitalisation units mance and assess continuous improvement. and follow-­up in outpatient clinics. The other procedures After the publication in 2015 of the last version of the were related to quality management, such as documenta- ISO 9001 standard, the QMS was adapted to the new tion control, audit performance, incident management, requirements. The major changes were the following: corrective actions, staff training, patient satisfaction moni- ► Determining the context of the organisation by toring, equipment and facilities maintenance, purchasing, conducting a SWOT (Strengths, Weaknesses, Oppor- and management relations with suppliers (online supple- tunities and Threats) analysis to identify and address mental appendix 1 (General Procedures)). potential risks to the programme and improve Twenty-­seven standard operating procedures and processes, considering internal strengths and external 28 care protocols were developed, 18 of which were opportunities. medical protocols and 10 were nursing protocols ► Inclusion of process risk management. The tool used (online supplemental appendix 2 (Standard Operating for risk analysis was the FMEA (Failure Mode and Procedures), online supplemental appendix 3 (Proto- Effect Analysis). Improvement actions were defined cols)). Seventy-­three specific forms were also created to and monitored to minimise the risks found. record the performance of the activity, and 45 indica- ► Consideration of the needs and expectations of all tors to monitor the effectiveness of the processes were stakeholders, creating opportunities for improvement established. Indicators were extracted from the recom- and objectives aimed at meeting the needs detected mendations and consensus documents of the scientific and satisfying expectations. The transplant unit iden- societies16 and, alternatively, we defined some indicator tified the relevant stakeholders, including patients, ad hoc for specific needs of our programme (table 1). relatives, transplant unit professionals from LTPs in Objectives (targets) were set for process and programme Spain, non-­transplant referral hospitals, national and indicators. regional transplant organisations, several patient asso- A system for recording incidents in outpatient consulta- ciations and scientific societies. tions, intensive care units, hospitalisation units and oper- Following the publication of the Spanish standard UNE ating rooms was established in order to detect problems, 179008 QMS for liver transplantation units in October failures or errors that could hinder the work of profes- 2016, the QMS was adapted to include the requirements sionals and patient recovery. Several safety checks were of this standard, which is based on ISO 9001:2015 and established to control critical key points in the processes, includes specific requirements for liver transplant units. as it was detected that a significant number of incidents The main changes made to implement it were the assess- occur at device changes (arrival in the operating room, ment of the risks of the processes focusing on patient intensive care unit and hospital ward), admission of the safety, reinforcing the competence of nursing staff, opti- living liver transplant donor and recipient patient, admis- mising the coordination between multidisciplinary teams sion of the cadaveric donor recipient patient, immediate (eg, to reduce the time from graft availability notification presurgical assessment, inpatient discharge information to recipient transplantation) and the establishment of and referral to outpatient clinics. effective communication channels with all stakeholders Patient satisfaction was assessed. For this purpose, a involved in the transplantation process. satisfaction survey is offered to all patients immediately In October 2017, the certificate of compliance with this before hospital discharge. In 2015, we introduced the standard was obtained, making our programme the first evaluation of family/caregiver satisfaction. in Spain to achieve this recognition. According to the ISO 9001 standard, an annual plan- ning of continuous training for staff to improve the skills Activity of the LTP since ISO 9001 certification until today needed to adapt to changes and innovations in their daily The activity of the LTP since obtaining the ISO 9001 work was established. In addition, the effectiveness of the compliance certification in 2011 until today, and the training received by all staff was evaluated. result of some process indicators, are shown in table 2. 4 López-­Púa Y, et al. BMJ Open Quality 2023;12:e002440. doi:10.1136/bmjoq-2023-002440 Open access Table 1 Liver transplant programme indicators Liver transplant programme indicators Pretransplant Intensive care unit/surgical intervention % Compliance with available signed and filled informed % Compliance with the checklist of the recipient (medical) consents % Compliance with available signed and filled informed % Compliance with the recipient checklist (nurse) transfusion consents % Of patients visited within 15 days from the request of the % Completion of the intensive care unit (ICU) admission report first visit (medical) % Patients presented in transplant committee in less than 90 % Compliance with the checklist on arrival at the ICU days after referral (medical) Rate of spontaneous visits to the pre-­liver transplant nurse’s % Completion of the ICU transfer report (medical) office % Patients who had transplants with preanaesthetic report Mean number of packed red blood cells % Living donors undergoing full study and evaluation in less % Completion of surgical report than 60 days % Completion of checklist: preoperative evaluation of living % Completion of anaesthesia report donors (nurse) % Completion of checklist: preoperative evaluation of % Completion of nursing report recipients (nurse) % Completion of checklist: preoperative evaluation of % Appearance of primary graft malfunction recipients (hepatologist) % Completion of checklist: preoperative evaluation of living donors (surgeon) Immediate post-­transplant Outpatient follow-­up % Patients with post-­transplant infections % Patients visited by the doctor in 15 days or less postliver transplant % Perioperative mortality (≤24 hours after surgery) % Patients visited by nursing staff in 15 days or less postliver transplant % Early liver retransplantation rate (≤7 days post-­transplant) % Early postliver transplant mortality (first month post transplant) Late liver retransplantation rate (except those in the first week) % Patient readmitted to ICU after liver transplant (index hospitalisation) Early re-­intervention rate (unscheduled intervention 15 days % Patient re-­admitted within 1 month after liver transplant postliver transplant) discharge % Completion with the nursing discharge report % Emergency room admission less than 1 month after liver transplant discharge Other indicators % Patient survival after liver transplantation: 1 year, 3 years, 5 years and 10 years Satisfaction of the patients who had a transplant % Graft survival after liver transplantation: 1 year, 3 years, 5 years and 10 years Average hospital stays after liver transplant Average ICU stay after liver transplant Average stay in the ward after liver transplant DISCUSSION of continuous improvement. The implementation of a The current study shows the steps, strengths and limita- QMS has led to changes in both the approach and the tions in the implementation of a QMS in an LTP. Working working method. The standardisation and protocolisa- under the requirements of a QMS in the LTP over these tion of processes led to less variability in daily clinical years has contributed to the adaptation to a new quality practice. For example, the introduction of a checklist at and safety culture focused on the patient. Activities are key moments such as the immediate preoperative assess- clearly protocolised; everything done is recorded, veri- ment ensures that all necessary preoperative activities fied done as planned and is done under the perspective are carried out. The systematisation of all activities allows López-­Púa Y, et al. BMJ Open Quality 2023;12:e002440. doi:10.1136/bmjoq-2023-002440 5 6 Table 2 Liver transplant programme activity since QMS certification 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Open access % Patients visited within 15 days of request for first visit 81 82 80 83 86 88 86 93 92 94 90 89 Patients initiating evaluation 193 211 240 223 178 168 123 163 173 143 144 152 Average days in evaluation 95 142 160 142 130 153 140 147 197 136 129 110 SD days in evaluation 89 112 147 128 145 177 165 153 183 127 124 90 Median days in evaluation 84 109 130 115 97 98 104 113 182 109 94 97 Patients included on waiting list 93 93 99 98 72 78 52 81 80 77 78 68 Patients included on waiting list in <3 months 53 39 34 37 34 37 22 32 25 31 37 32 % Patients on waiting list in <3 months 54 42 34 38 47 47 42 40 31 40 47 47 % Patients with preanaesthesia report 50 59 75 87 97 93 89 89 87 87 100 98,6 Median MELD (Model for End-­stage Liver Disease) Score 21 20 22 23 21 22 22 21 20 23 23 23 (range) 14–23 12–22 15–25 17–26 14–26 18–25 17–24 18–25 15–26 17–24 21–30 18–26 Transplanted patients 73 72 74 66 67 67 58 64 81 67 54 75 % Patients with post-­transplant infections 22 34 28 45 33 30 32 19 23 30 22 30 % Perioperative mortality (≤24 hours after surgery) 1.4 0 1.4 1.5 1.5 1.5 0 1.6 0 1.4 0 1.3 % Early liver retransplantation rate (≤7 days post-­transplant) 4.1 1.4 4.1 1.5 2.9 0 1.7 1.6 0 0 0 0 % Early post-­liver transplant mortality (first month post-­transplant) 0 0 2.8 3 3.1 3 3.5 3.2 1.2 2.9 7.4 5.3 % Patient survival after liver transplantation: 1 year 95.5 91.4 94.1 95.4 96.6 91.9 92.3 94.7 96 93.9 92.5 – % Patient survival after liver transplantation: 3 years 89.4 87.1 86.8 93.9 91.4 85.5 80.8 93 91 – – – % Patient survival after liver transplantation: 5 years 84.9 80 79.4 89.2 89.7 80.7 76.9 – – – – – % Patient survival after liver transplantation: 10 years 65.2 71.4 – – – – – – – – – – % Graft survival after liver transplantation: 1 year 90.4 88.9 89.2 93.9 91 91 91.4 89.1 93 92.5 90.7 – % Graft survival after liver transplantation: 3 years 84.9 84.7 79.7 89.4 85.1 82.1 79.3 89.1 86 – – – % Graft survival after liver transplantation: 5 years 79.5 76.4 71.6 84.9 82.1 77.6 75.9 – – – – – % Graft survival after liver transplantation: 10 years 57.5 69.4 – – – – – – – – – – Average hospital stays after liver transplant (days) 20.5 20.2 22.5 20 18 18.7 21.5 16.6 19.4 19 15.7 18.9 Patient satisfaction (% with score of 9/10 or 10/10) 92 96 91 100 95 80 95 100 92 98 95 95 Family/caregivers satisfaction (% score of 9/10 or 10/10) – – – – 97 89 100 100 100 96 92 95 QMS, quality management system. López-­Púa Y, et al. BMJ Open Quality 2023;12:e002440. doi:10.1136/bmjoq-2023-002440 Open access for greater professional autonomy and helps new staff to aspects of comfort (eg, noise in the ward) and the infor- become more familiar with the work dynamics, leading to mation received regarding medication and its side effects, a shorter adaptation period. The record of incidents has families focused on the provision of more psychological allowed the detection of problems or errors in daily assis- support to patients, the small size of the rooms and the tance. Through the analysis of these incidents, corrective lack of single rooms. During the COVID-­19 pandemic, measures have been applied, and some risks have been families and caregivers also complained about the restric- identified and addressed. tion of visits. The incorporation of indicators into process moni- We have established continuous feedback with patient toring makes it possible to evaluate the effectiveness of associations by providing satisfaction surveys of hospi- improvement actions. In the current study, it was observed tals that refer patients for transplantation, educational that some indicators apparently worsened or at least did actions (meetings) and information (videos, booklets) on not improve. Several reasons may explain this lack of the care of patients on the waiting list and patients who improvement: (1) An increased detection and recogni- had transplants, with participation in meetings and webi- tion of protocol violations that were already present but nars led by patient associations. unrecognised before the implementation of the QMS, (2) Although all governmental health policies encourage Very high values in some indicators, almost impossible to and promote the provision of comprehensive health- improve (eg, survival at 1 year) and (3) The increase of care to achieve high-­ quality standards and the devel- the associated pathologies that require a more complex opment and implementation of quality systems,3–7 the evaluation, prolonging the period of time before the scarcity of resources in public health organisations can inclusion on the waiting list. be a limiting factor for the implementation of a QMS. Moreover, it should be considered that the saturation This lack of resources leads to a greater effort on the of the hospital services that perform the complementary part of professionals, which can lead to rejection and tests requested for the evaluation of patients can alter the lack of commitment, precluding the certification of a activity of the programme. The QMS has tools to iden- clinical unit. At the start of the project, the main barriers tify these disruptions and implement actions to mitigate were the number of hours spent on document prepara- them. It is helpful to identify those responsible for these tion and implementation, the financial costs of quality services and establish fluid communication channels with consultants (although this should be seen as an invest- these professionals to resolve these disturbances. ment rather than expense) and the reluctance of some Indicators related to the per cent of compliance with team members regarding the expected effect of the QMS. safety checklists are not shown because they stopped Another reason that could limit the implementation of being monitored in 2015 due to the target value being a QMS is the lack of specific standards. In the absence reached in all of them a few years earlier. It is possible that of specific models for certifying activities carried out in the QMS has played a significant role in the maintenance the healthcare field, except for the Joint Commission,17 of these high-­quality standards. Although the major chal- the most widely used model for the implementation of a lenge and complication of the project was to adapt the QMS is currently offered by the ISO 9001:2015 standard. complex activity of liver transplantation to a non-­specific Although the ISO 9001 standard can be applied to any standard outside the clinical setting without losing its type of organisation, and healthcare professionals may clinical care orientation, we believed and confirmed by consider its adaptation to health processes to be complex, our experience that we got over this limitation. the UNE 179008:2016 standard may help liver transplant The implementation of a continuous training units to adhere to the QMS systems. A specific limita- programme is also an important consequence of the tion of the study is that it shows the process in a specific QMS, particularly for nursing staff, updating and country (Spain). The main limitation of our study refers increasing of knowledge in relation to the transplant to the applicability of our experience to other hospitals. process. Regarding the content of the training sessions, Our QMS integrates European and Spanish legislation on the professionals are asked for topics they find most inter- liver transplantation, recommendations of Spanish scien- esting and/or useful for their job. The continuous evalu- tific societies, and is adapted to the conditions and guide- ation of the teachers and alumni allows a measurement lines of the hospital, and the UNE 179008 standard is only of the effectiveness of the training, and the information is recognised in Spain. Another limitation is the changing tailored to the needs of the professionals. context of liver transplantation, especially in Spain, with Attending to the needs and expectations of patients a very high rate of organ donation. Therefore, several and their families by providing feedback from satisfaction process and outcome indicators and risk-­based strategies surveys and patient complaints allows us to improve our are likely not applicable to other countries, especially to service. The results, in terms of overall satisfaction from non-­public healthcare LTPs and possibly not useful else- families’ responses, are very similar to those reported by where. The study has limitations as to whether the results patients. We found some differences between patients and the QMS proposed are fully acceptable for the LTPs and families/caregivers regarding the identification in other countries. of areas with room for improvement. While the main For future studies we plan to include some patient-­ concerns of patients focused on the taste of the food, related measures as performance indicators: Patient López-­Púa Y, et al. BMJ Open Quality 2023;12:e002440. doi:10.1136/bmjoq-2023-002440 7 Open access Reported Outcome Measure and Patient Reported Experience Supplemental material This content has been supplied by the author(s). It has Measure with our Patient Experience Group, including not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-­reviewed. Any opinions or recommendations discussed are solely those some focus-­group meetings with patients, and with the of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and goal to create patient-­ centred outcome measures for responsibility arising from any reliance placed on the content. Where the content liver transplantation in the context of the International includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, Consortium for Health Outcomes Measures. terminology, drug names and drug dosages), and is not responsible for any error We would like to emphasise that the implementation of and/or omissions arising from translation and adaptation or otherwise. the QMS has been associated with a substantial change in Open access This is an open access article distributed in accordance with the the working style, opening participation in clinical proto- Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which cols and updating guidelines or in the choice of quality permits others to distribute, remix, adapt, build upon this work non-­commercially, and license their derivative works on different terms, provided the original work is objectives to all staff, becoming aware of key aspects of properly cited, appropriate credit is given, any changes made indicated, and the use patient safety, comfort and perception of treatment. We is non-­commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. would also like to highlight that the updating and creation ORCID iD of clinical protocols and working procedures has contrib- Yolanda López-­Púa http://orcid.org/0009-0001-5741-8577 uted to the retention of the knowledge acquired over the years by the senior and experienced professionals, which translates to the application of the best clinical practices REFERENCES and the achievement of better results. In addition, it 1 Lorenzo S, Joaquín Mira J, Sánchez E. Gestión de Calidad total Y has led to an increase in the commitment of our profes- Medicina Basada en La Evidencia. Medicina Clínica 2000;114:460–3. 2 Ferlie EB, Shortell SM. Improving the quality of health care in the sionals, an essential aspect that has allowed us to main- United Kingdom and the United States: a framework for change. tain our certification from 2011 to the present. We can Milbank Q 2001;79:281–315. 3 WHO Working Group. The principles of quality assurance. conclude that it is possible to adapt the complex activity International Journal for Quality in Health Care 1989;1:79–95. of liver transplantation to a non-­specific standard such as 4 WHO. Quality of care. Available: https://www.who.int/health-topics/​ quality-of-care#tab=tab_1 [Accessed May 2023]. ISO 9001 without losing its clinical care orientation, and 5 Bottaro S, Garel P, Agra Y. European network for patient safety and that this implementation has helped us to improve the quality of care: PaSQ. Revista de Calidad Asistencial 2016;31(S):1–3. performance of our activity. 6 Ley 14/1986, De 25 de Abril, General de Sanidad. BOE Núm. 102, De 29/04/1986. BOE-­A-­1986-­10499. n.d. Available: https://www.boe.es/​ We encourage liver transplantation programmes to eli/es/l/1986/04/25/14 implement a QMS to improve the efficiency of their 7 Ley 16/2003, De 28 de Mayo, De Cohesión Y Calidad del Sistema Nacional de Salud. BOE Núm. 128, De 29/05/2003. BOE-­A-­ processes, promote quality and safety in patient care, and 2003-­10715. n.d. Available: https://www.boe.es/eli/es/l/2003/05/28/​ achieve a greater satisfaction among the professionals 16/con 8 International Organization for Standarization. ISO 9001:2015 quality involved in liver transplantation. management systems. Requeriments, 2015. 2015. Available: https:// Twitter Jordi Colmenero @ColmeneroJordi www.iso.org/standard/62085.html) 9 Astrini N. ISO 9001 and performance: a method review. Total Quality Management & Business Excellence 2021;32:5–32. Acknowledgements Dr Marta Arias, Dr Gabriela Gutiérrez, Dr Mercè Brunet and 10 Fonseca L. From quality gurus and TQM to ISO 9001:2015: a review Mrs Magalí Castella. of several quality paths. International Journal for Quality Research 2015;9:167–80. Contributors Conceptualisation, methodology, investigation, writing-­review and 11 Fonseca L, Domingues P, Nóvoa H, et al. ISO 9001:2015: the editing: YLP, MN, AT, JR and JC. Data curation and review: YLP, MN, JC, RG, EL, view from the conformity assessment community. Total Quality AD, AG and JR. Formal analysis, validation, writing original draft, supervision: Management & Business Excellence 2023;34:558–79. YLP, MN and AT. All authors approved the final submitted manuscript. Guarantor: 12 Shaw CD, Groene O, Botje D, et al. The effect of certification and YLP. accreditation on quality management in 4 clinical services in 73 European hospitals. Int J Qual Health Care 2014;26 Suppl 1:100–7. Funding The work by JC had support from Agència de Gestió d’Ajuts Universitaris 13 Enders C, Lang GE, Lang GK, et al. ISO 9001:2015 certification in i de Recerca (AGAUR, grant SGR 2021) and Carlos III Institute of Health (ISCIII, quality management. Klin Monbl Augenheilkd 2017;234:886–90. Ministry of Economy and Competitiveness, Spain cofunded by EU, grant 14 Shaw CD. External quality mechanisms for health care: summary PI22/01234). of the expert project on visitatie, accreditation, EFQM and ISO assessment in European Union countries. International Journal for Competing interests None declared. Quality in Health Care 2000;12:169–75. Patient and public involvement Patients and/or the public were not involved in 15 Spanish Association for Standardization. UNE 179008:2016 quality the design, or conduct, or reporting, or dissemination plans of this research. management systems for liver transplantation units. 2016. Available: https://www.une.org/encuentra-tu-norma/busca-tu-norma/norma?c=​ Patient consent for publication Not applicable. N0057288) 16 Sociedad Española de Trasplante Hepático (SETH). Consensus Ethics approval Not applicable. document of the Spanish society of liver transplantation. waiting lists, Provenance and peer review Not commissioned; externally peer reviewed. liver transplantation and quality indicators. Gastroenterol Hepatol 2009;32:702–16. Data availability statement All data relevant to the study are included in the 17 Joint Commission International standard. n.d. Available: https://www.​ article or uploaded as supplementary information. jointcommissioninternational.org/standards/ 8 López-­Púa Y, et al. BMJ Open Quality 2023;12:e002440. doi:10.1136/bmjoq-2023-002440