Review of the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) version 2:2015

Abstract

Background: In 2011 the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) was launched, aimed at strengthening the quality and competence of African clinical, public health and reference laboratories. We reviewed the first version of the SLIPTA checklist in 2011. The continued development and publication of a new version of the International Organization for Standardization (ISO) 15189 standard demands a renewed review.Objective: This study aimed to determine the suitability of SLIPTA in guiding laboratories towards ISO 15189:2012 compliance and accreditation and provide recommendations for further SLIPTA improvement.Methods: The study was conducted between September 2018 and April 2019. Coverage of ISO 15189:2012 by SLIPTA checklist version 2:2015 was determined and the point distribution of the scoring system over the different sections of the SLIPTA checklist was re-investigated. These findings were compared with the review of the first version of the SLIPTA checklist (based on ISO 15189:2007) and with findings published on SLIPTA implementation and roll-out.Results: The coverage of ISO 15189 by the SLIPTA checklist has increased, even though ISO 15189:012 is more extensive than ISO 15189:2007. The point distribution is still skewed towards sections related to quality planning rather than quality control and improvement. Although to date 314 laboratories have been assessed, barriers for laboratories to participate in SLIPTA are high. Sustainability of SLIPTA results is insufficiently studied.Conclusion: SLIPTA checklist version 2:2015 has improved compared to earlier versions. We recommend increasing accessibility for laboratories to participate and increasing guidance for ISO-based quality management system implementation.

Using the SLIPTA checklist to assess laboratory readiness for Joint Commission International accreditation

“…The level of compliance of SLIPTA with JCI requirements appears to be lower than its compliance with ISO 15189, as determined by Datema et al 8 This observation is because the SLIPTA checklist is primarily based on the ISO 15189 and the Clinical and Laboratory Standards Institute guideline QMS01-A4 clauses in 2009. 9 The SLIPTA checklist and JCI standards are structured differently.…”

“…7 With increased outbreaks of diseases such as HIV, tuberculosis, and the recently emerging coronavirus disease 19 in low-and middle-income countries (LMICs), there is increased attention on strengthening healthcare systems in limited-resource areas. 8 In 2009, the World Health Organization Regional Office for Africa, in collaboration with the African Society for Laboratory Medicine, the United States Center for Disease Control and Prevention and African countries consorted on the creation of a Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) to implement quality management systems (QMS) and organise quality improvement processes in LMIC laboratories. 9 The SLIPTA programme consists of a checklist questionnaire linked to a five-star recognition depending on the level of compliance ranging from ≤ 55% (0 stars) to ≥ 95% (5 stars).…”

“…9 The SLIPTA programme consists of a checklist questionnaire linked to a five-star recognition depending on the level of compliance ranging from ≤ 55% (0 stars) to ≥ 95% (5 stars). 8,9 It is an interim recognition, and laboratories that achieve a SLIPTA five-star rating are encouraged to apply for international accreditations such as ISO 15189:2012 and Joint Commission International (JCI). 8 Founded in 1951, JCI is today the largest international accreditation body for hospitals.…”

“…8,9 It is an interim recognition, and laboratories that achieve a SLIPTA five-star rating are encouraged to apply for international accreditations such as ISO 15189:2012 and Joint Commission International (JCI). 8 Founded in 1951, JCI is today the largest international accreditation body for hospitals. 11 The JCI laboratory accreditation standards cover all laboratory needs for continual improvement within a quality management environment.…”

“…With increased outbreaks of diseases such as HIV, tuberculosis, and the recently emerging coronavirus disease 19 in low- and middle-income countries (LMICs), there is increased attention on strengthening healthcare systems in limited-resource areas. 8 …”