Articoli in pubblicazione

Introduction: it is nowadays recognized that, in low income countries, the development of quality-assured laboratory services is a major part of a greater framework of health system strengthening and that limited laboratory capacity represents a major barrier to implementation and sustainability of prevention, treatment and care programs. Acknowledging this need, the North Kinangop Catholic Hospital clinical laboratory (Kenya) pursued and obtained ISO 15189 accreditation in clinical biochemistry and haematology.
Methods: the present paper describes the steps that led to this accomplishment in January 2019, as a result of a three-year project. Methodological support was provided by the School of Medicine (Maryland University, USA) as part of an American government program aimed to reinforce laboratory services in resource-poor countries. The iterative plan–do–check–act method was applied.
Results: major changes in laboratory management were introduced to meet the requirements of the standard. Analytical quality issues were reviewed; Internal Quality Control and External Quality Assessment procedures were implemented; reorganization of laboratory areas was made. The North Kinangop Catholic Hospital Laboratory obtained ISO 15189 accreditation in January 2019, as a result of a process started in March 2016.
Conclusions: a key to the success was professional commitment, sharing of values and external support, although careful planning resulted to be the key issue; actually, in low income countries social, political and even logistical peculiarities pose unique challenges.

In the last decades, the landscape of clinical laboratories has experienced monumental changes due to both technological developments and new challenges. Laboratory medicine has been strongly influenced by technological developments, but also by a wide range of other issues such as the healthcare system organization, medical practice and, more recently, patient empowerment. In the coming decade, many and different trends will intersect, interact, and over lap each other, and with current laboratory practices. These dramatic innovations make of critical importance for leaders to prepare for a future with the understanding of possible collisions between linear trends and nonlinear external forces. The aim of the present paper is to discuss the future of clinical laboratories according to two different approaches: technological and professional viewpoints. In particular, a revised version of the “ten points manifesto” for the future of laboratory professionals is described, with a focus on the main drivers and efforts that should be done to demonstrate the added value and true role of laboratory medicine in modern health care systems. The main goal of the manifesto is to emphasize the central role and the vital contribution of clinical laboratories and their professionals to improved health care, patient safety and clinical outcomes.