ISO 15189 all’ombra dell’Equatore. Descrizione dell’esperienza del NorthKinangop Catholic Hospital Laboratory in Kenya
ISO 15189 in the shadow of the Equator. Description of the experience in the North Kinangop Catholic Hospital Laboratory (Kenya)

AUTORI

ABSTRACT

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.

BIBLIOGRAFIA