Background The aim was to improve the overall quality management system for the Department of Pathology and Laboratory Medicine by attaining international accreditation to A2LA ISO 15189, in order to provide accurate, reliable, and timely results for excellent patient care and patient safety. The accreditation of laboratory medicine improves all processes in the laboratory, including reduction of errors in the pre-analytical, analytical, and post-analytical processes, facilitation of accurate and rapid diagnostics, participation in acceleration and efficiency of treatment, and stimulation of continuous improvement; therefore, the decision was taken to aim for A2LA ISO 15189 accreditation.

Methods

• Baseline assessment of the serology section was chosen as the model of implementation once successfully completing of all the identified gaps from the ISO 15189 standard.

• Development of project management action plan and agreed upon timeline:

  • Accreditation Project Initiation 2015

  • Accreditation Project Identification and Planning 2015–2016

  • Accreditation Project Execution 2016–2017

• The ISO 15189 parameters were applied to the serology section and monitored by use of key performance indicators (KPIs).

  • Accreditation Project control 2017

• The control was through performing internal audits and then taking corrective action with preventive action.

  • Accreditation Project Closeout 2018

• The project was submitted for application to the American Association for Laboratory Accreditation ISO 15189.

Results Internal audits were performed from the baseline audit in 2015 to the final exit audit in 2018. The results for all the sections were as follows:

Chemistry: 2015 - 20%; 2016 - 40%; 2017 - 46%; 2018 - 95%.

Hematology: 2015 - 51%; 2016 - 60%; 2017 - 62%; 2018 - 91%.

Microbiology: 2015 - 19%; 2016 - 40%; 2017 - 46%; 2018 - 85%.

Serology: 2015 - 52%; 2016 - 65%; 2017 - 83%; 2018 - 95%.

Receiving OPD: 2015 - 39%; 2016 - 52%; 2017 - 70%; 2018 - 90%.

Blood bank: 2015 - 20%; 2016 - 50%; 2017 - 70%; 2018 - 83%.

Molecular biology: 2016 - 20%; 2017 - 60%; 2018 - 85%.

Histopathology: 2015 - 15%; 2016 - 30%; 2017 - 60%; 2018 - 89%.

From the results, between 2016 and 2018, a dramatic increase in compliance was demonstrated, and therefore preparation for the final A2LA ISO 15189 audit was executed.

Conclusion An essential component of successful implementation of A2LA ISO 15189 was the coordination and rapport between management and staff. Well-trained and well-motivated laboratory staff were required to implement the system. The initial gap analysis and then the continuous monitoring through internal and external assessment provided invaluable tools for the successful accreditation to ISO 15189:2012 for more than 250 tests. The Department of Pathology and Laboratory Medicine was the first laboratory in KSA to gain the A2LA ISO 15189 accreditation.