Implementation of a quality management system in a liver transplant programme.
quality improvement
quality measurement
transplantation
Journal
BMJ open quality
ISSN: 2399-6641
Titre abrégé: BMJ Open Qual
Pays: England
ID NLM: 101710381
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
received:
02
06
2023
accepted:
07
09
2023
medline:
4
10
2023
pubmed:
26
9
2023
entrez:
25
9
2023
Statut:
ppublish
Résumé
The management of liver transplantation has become a complex process involving different healthcare professionals. Teamwork, standardisation and definition of the best practices are essential for success, patient satisfaction and society's favourable perception of transplantation programmes.ISO 9001:2015 certification provides the necessary elements to help implement a quality management system (QMS) to ensure that patient care is performed with the highest guarantees of clinical quality and safety. The aim of this study is to describe the steps, strengths and limitations in the implementation of a QMS in a liver transplant programme (LTP). This included analysing the starting point, setting up a working group, training, defining the scope of certification, preparing documentation, and conducting an internal and external audit, which culminated in the ISO 9001 quality certification award. The scope of QMS includes all the processes of LTP, from referral of candidates to long-term follow-up after transplantation. The project was structured in seven phases that took place between 2008 and 2011. The implementation of QMS led to the generation of all the necessary documentation to meet the requirements of the standard, including internal and legal requirements related to the transplant activity. The establishment of indicators to measure the effectiveness of processes, risk management and the identification of incidents allows us to implement measures devoted to avoiding the deficiencies and to meet the established objectives. ISO 9001:2015 certification has contributed to the adaptation of a new quality and safety culture focused on the patient. All activities are protocolised, everything is recorded, measured, and verified, and all steps are taken as planned. Work is carried out in terms of continuous improvement. This has led to less variability in daily clinical practice and a better understanding of work dynamics.
Sections du résumé
BACKGROUND
The management of liver transplantation has become a complex process involving different healthcare professionals. Teamwork, standardisation and definition of the best practices are essential for success, patient satisfaction and society's favourable perception of transplantation programmes.ISO 9001:2015 certification provides the necessary elements to help implement a quality management system (QMS) to ensure that patient care is performed with the highest guarantees of clinical quality and safety. The aim of this study is to describe the steps, strengths and limitations in the implementation of a QMS in a liver transplant programme (LTP).
PROJECT MANAGEMENT METHOD
This included analysing the starting point, setting up a working group, training, defining the scope of certification, preparing documentation, and conducting an internal and external audit, which culminated in the ISO 9001 quality certification award. The scope of QMS includes all the processes of LTP, from referral of candidates to long-term follow-up after transplantation.
RESULTS
The project was structured in seven phases that took place between 2008 and 2011. The implementation of QMS led to the generation of all the necessary documentation to meet the requirements of the standard, including internal and legal requirements related to the transplant activity. The establishment of indicators to measure the effectiveness of processes, risk management and the identification of incidents allows us to implement measures devoted to avoiding the deficiencies and to meet the established objectives.
CONCLUSION
ISO 9001:2015 certification has contributed to the adaptation of a new quality and safety culture focused on the patient. All activities are protocolised, everything is recorded, measured, and verified, and all steps are taken as planned. Work is carried out in terms of continuous improvement. This has led to less variability in daily clinical practice and a better understanding of work dynamics.
Identifiants
pubmed: 37748820
pii: bmjoq-2023-002440
doi: 10.1136/bmjoq-2023-002440
pmc: PMC10533803
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Gastroenterol Hepatol. 2009 Dec;32(10):702-16
pubmed: 19732993
Qual Assur Health Care. 1989;1(2-3):79-95
pubmed: 2490962
Milbank Q. 2001;79(2):281-315
pubmed: 11439467
Klin Monbl Augenheilkd. 2017 Jul;234(7):886-890
pubmed: 28743138
Int J Qual Health Care. 2014 Apr;26 Suppl 1:100-7
pubmed: 24615598
Med Clin (Barc). 2000 Apr 1;114(12):460-3
pubmed: 10846701
Rev Calid Asist. 2016 Jun;31 Suppl 1:1-3
pubmed: 26946969
Int J Qual Health Care. 2000 Jun;12(3):169-75
pubmed: 10894187