The Strengthening Laboratory Management Towards Accreditation (SLMTA) program by the World Health Organization African Regional Office (WHO-AFRO) aims to improve the quality of laboratory services by offering management training through serialized workshops with respective laboratories in the developing world. SLIPTA, or Stepwise Laboratory Improvement Towards Accreditation, is a checklist and scoring system, also developed by WHO-AFRO, which can be used to measure the quality improvements. A well functioning national laboratory system is made up of components of leadership, organizational structure, policy and regulations, testing services, referrals and networks, infrastructure, human resources, reagents and equipment procurement and supply, information management, financing, quality and bio-risk management systems. Within the individual laboratory, the SLMTA program aims to deliver task-based quality and laboratory management training to the manager in order to produce measurable results towards improvement of laboratories for WHO-AFRO accreditation.
The East African Public Health Laboratory Networking Project (EAPHLNP), using regional assessors from all five East African Partner States, recently conducted an assessment of its satellite laboratories’ quality systems. The assessment gathered baseline information on the implementation of quality systems in the satellite laboratories, to gauge the progress of laboratories towards ISO 15189 accreditation. ISO 15189 is a medical laboratory accreditation program that presents requirement related to quality management than to operational procedures – it is a standard that ensures that labs are competent and effective in quality management of its staff and services. “ISO 15189 is an international quality management system standard designed specifically for medical laboratories. It outlines the controls required to manage risks that may have an impact on the validity of examination results, and tools to help the laboratory to improve its operations and customer satisfaction” (NATA, 2012). Under SLIPTA quality systems management guidelines, the following areas were assessed (see insert for more detail on each):
- Documents and records
- Management Reviews
- Organization & Personnel
- Client Management & Customer Service
- Internal Audit
- Purchasing & Inventory
- Process Control and Internal & External Quality Assessment
- Information Management
- Corrective Action
- Occurrence/Incidence Management & Process Improvement
- Facilities and Safety
According to the results of the regional peer assessment, and based on mean scores per category, laboratories in the Partner States had the following strengths and weakness:
|Facilities and safety||✔||✔||✔||✔||✔||Occurrence management||✖||✖||✖||✖||✖|
|Purchasing & inventory||✔||✔||✔||✔||✔||Internal audit||✖||✖||✖||✖|
|Organisation & personnel||✔||✔||✔||Documents & records||✖||✖||✖|
|Information management||✔||Customer service||✖||✖|
|Process control (EQA/IQC)||✔||Management reviews||✖||✖||✖|
|Process control (EQA/IQC)||✖|
It is recommended, according to SLIPTA, that ways to improve and increase laboratory ranking are to follow these general steps:
- Identify areas of improvement
- Develop and implement a work plan
- Monitor laboratory progress
- Conduct retesting
- Continue steps to achieve accreditation
An improvement in the 12 quality system essentials indicates an adherence to the requirements for accreditation in terms of quality and competency. Some of the worst performing EAPHLNP satellite laboratories according to the assessment had no proper mechanisms for corrective action and occurrence management, and inadequate performance in all other aspects of quality management. While improvements should be targeted to all aspects, projects should also be achievable in the medium term in order to see continual improvement in the performance score. A laboratory may choose a critical path for completing activities towards quality improvement within the shortest time possible.
Maruta et.al (2012) suggest that drastic improvements can be made within a matter of weeks from zero to two or three stars on the SLIPTA scale. The improvement projects took about six weeks with 10-week mentorship investments. Mentorship is an extension of didactic learning and training, offering a work place based and iterative learning experience. Laboratories studied in Lesotho improved client management within 10 weeks of mentorship to a 100% score, followed by marked improvements in management reviews, facilities and safety and occurrence management and greatest percent improvement in management reviews and internal audits. The study also indicated that it may take a differential amount of time to achieve improvements depending on area of improvement, and percent improvements (not necessarily 100%) can markedly improve the performance ranking of a laboratory. Also, certain areas are critical to target first for continual improvement of the laboratory.
Management review entails a work-plan & budget, quality management system improvement measures, and a communications system on laboratory operations; internal audit need to be followed by audit recommendations action plans and follow up; and corrective actions include comprehensive occurrence reports, troubleshooting and cause analysis, documentation of corrective action, discordant result tracking and corrective action. According to Maruta et.al (2012), these elements are crucial to the improvement process as a whole.
Many laboratories in Uganda and Tanzania failed in corrective action; management reviews were a weakness in Kenya, Rwanda and Burundi. Internal audit was a general quality system weakness for laboratories in all countries of the EAC except Uganda. Individually, laboratories had varied performance on each component of the quality management system and thus, while improving the three crucial elements, laboratories must undertake to continually improve all other aspects.
One of the key improvements suggested by the Laboratory Technical Working Group of the EAPHLNP was that a mentorship approach should be employed in all laboratories. As earlier stated, a mentorship approach will ensure effective implementation of improvement projects and the sustainability of good performance. In addition, the EAPHLNP TWG suggested full coverage of SLMTA enrolment among satellite laboratories, training of mentors, internal auditors and assessors; strengthening of Laboratory Networking and Accreditation TWG within each Partner State; and follow up evaluations as measures to ensure continual progress of regional satellite laboratories towards accreditation. Two stars or higher for all satellite laboratories is required in the next few years in order to accelerate support for diagnostic services for vulnerable populations and effectively increase the involvement of laboratories in disease surveillance.
- World Health Organization – Regional Office for Africa. “Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) Checklist: For Clinical and Public Health Laboratories”
- Maruta T, Motebang D, Wanyoike J, Peter T, Rotz PJ. “Impact of mentorship on WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA).” Afr J Lab Med. 2012; 1(1), Art. #6, 8 pages. http://dx.doi.org/10.4102/ ajlm.v1i1.6
- National Association of Testing Authorities. (NATA) 2012. “Understanding ISO 15189 – Accreditation Requirements for Medical Laboratories” http://www.nata.asn.au/training?page=shop.product_details&product_id=24&category_id=8&vmcchk=1
- World Health Organization. April 2012. Laboratory Assessment Tool.
- 21st Nov – 2nd Dec 2011. “Peer Assessment Of Satellite Laboratories Under The East Africa Public Health Laboratories Networking Project (EAPHLNP)” East African Public Health Laboratory Networking Project. Unpublished.
- 3. Yao K, et.al. “Improving Quality Management Systems of Laboratories in Developing Countries: An Innovative Training Approach to Accelerate Laboratory Accreditation” Am J Clin Pathol 2010; 134: 401-409