Enhancing accreditation outcomes for medical laboratories on the Strengthening Laboratory Management Toward Accreditation programme in Kenya via a rapid results initiative

Abstract

Background: Since 2010, Kenya has used SLIPTA to prepare and improve quality management systems in medical laboratories to achieve ISO 15189 accreditation. However, less than 10% of enrolled laboratories had done so in the initial seven years of SLMTA implementation.Objective: We described Kenya’s experience in accelerating medical laboratories on SLMTA to attain ISO 15189 accreditation.Methods: From March 2017 to July 2017, an aggressive top-down approach through high-level management stakeholder engagement for buy-in, needs-based expedited SLIPTA mentorship and on-site support as a rapid results initiative (RRI) was implemented in 39 laboratories whose quality improvement process had stagnated for 2–7 years. In July 2017, SLIPTA baseline and exit audit average scores on quality essential elements were compared to assess performance.Results: After RRI, laboratories achieving greater than a 2-star SLMTA rating increased significantly from 15 (38%) at baseline to 33 (85%) (p 0.001). Overall, 34/39 (87%) laboratories received ISO 15189 accreditation within two years of RRI, leading to a 330% increase in the number of accredited laboratories in Kenya. The most improved of the 12 quality system essentials were Equipment Management (mean increase 95% CI: 5.31 ± 1.89) and Facilities and Biosafety (mean increase [95% CI: 4.05 ± 1.78]) (both: p 0.0001). Information Management and Corrective Action Management remained the most challenging to improve, despite RRI interventions.Conclusion: High-level advocacy and targeted mentorship through RRI dramatically improved laboratory accreditation in Kenya. Similar approaches of strengthening SLIPTA implementation could improve SLMTA outcomes in other countries with similar challenges.

Quality and resilience of clinical laboratories in Rwanda: a need for sustainable strategies

“…However, there are limited publications addressing how laboratories involved in SLMTA sustain their achieved quality performance and progress towards accreditation. A study conducted in Kenya, seven years after the SLMTA phase-out, reported outcomes similar to our study [ 30 ]. The interventions of training of personnel in LQMS, mentorship, and assessments, as seen in the group two laboratories’ interventions in our study, also led to positive outcomes in Kenya [ 30 ].…”

“…A study conducted in Kenya, seven years after the SLMTA phase-out, reported outcomes similar to our study [ 30 ]. The interventions of training of personnel in LQMS, mentorship, and assessments, as seen in the group two laboratories’ interventions in our study, also led to positive outcomes in Kenya [ 30 ]. A recently published study, collecting data spanning seven years starting in 2013, on medical laboratories implementing quality management systems in Sub-Sahara Africa, indicates that a national framework including laboratory policies and a strategic planning is likely to facilitate ISO 15,189 standard accreditation [ 31 ].…”

Examining 7 years of implementing quality management systems in medical laboratories in sub‐Saharan Africa

“…However, accreditation preparedness can be attained from a lower star level depending on resources and dedication. [ 16 , 17 ]. SLIPTA certificates are not designed to recognise technical competence for any test.…”

Щодо Питання Акредитації Калібрувальних Та Вимірювальних Лабораторій: Загальний Аспект

“…Із зарубіжних авторів варто відзначити такі роботи як: Sartori S., Pfeifer T., Crossman M., KBr K. canuto, Ferraris, Gallorini M., Moretti Laura, Peisino, Ferrero C., Balsamo A., Pogliano U. [6], GROUP EA-LC, Ferrero C. [7], Karaaoui Abdul, Assaf Nada [8], Makokha Ernest, Ondondo Raphael, Kimani Daniel, Gachuki Thomas, Basiye Frank, Njeru Mercy, Junghae Muthoni, Downer Marie, Umuro Mamo, Mburu Margaret, Mwangi Jane [9], Oliver Anthony [10], Grochau Ines, Leal Dayane, Caten Carla [11], Tanhehco Yvette, Schwartz Joseph [12], Richter Karol, Erard Luc, Ferrero C., Cofrac Gabriel, Crossman Mike [13], Moreno Silva Patricia, Uribe Ardila Alfredo [14], El Marsafawy Hesham, Roy Rumpa, Ali Fahema [15], Caten Carla [16] [17,18,19] Процес акредитації має кілька переваг [17], як було зазначено раніше, однак найважливішою з них є переваги для клієнта/клієнтів, які використовують послуги лабораторії. Перевагами можуть бути підвищена довіра клієнтів до звітів про випробування, виданих лабораторією, і це призводить до потенційного зростання бізнесу завдяки підвищенню довіри клієнтів і задоволеності.…”