APIN SUPPORT FOR THE ACCREDITATION OF NIMR CENTER FOR HUMAN VIROLOGY AND GENOMICS (CHVG) TO ISO 15189:2012

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APIN SUPPORT FOR THE ACCREDITATION OF NIMR CENTER FOR HUMAN VIROLOGY AND GENOMICS (CHVG) TO ISO 15189:2012


Until September 2016, the Center for Human Virology and Genomics (CHVG) in NIMR was supported by APIN in different capacities in the delivery of quality laboratory services for the HIV program in Nigeria. During this period, the centre received support for state-off-the-art services through the provision of hi-tech automated diagnostic equipment, infrastructural upgrade, alternative power supply, equipment maintenance, reagent supplies, trainings, mentorship, supportive supervision, and other forms of human resource development and system strengthening. The laboratory was fully supported to implement a comprehensive quality management system (QMS), using the QMS model developed by Clinical and Laboratory Standards Institute (CLSI).

Following a resolution by the World Health Organization-Africa Regional Office (WHO AFRO) to strengthen laboratory systems of WHO AFRO member States and accelerate national laboratory service capacity building towards accreditation in the African Region, the Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program was the launched in 2009. The program involve the enrolment and participation of laboratories in the Strengthening Laboratory Management Towards Accreditation (SLMTA) training process and the SLIPTA audits  APIN supported the selection and enrolment of NIMR Center for Human Virology and Genomics to participate in the pilot cohort of the SLMTA program in 2010. The center was supported by APIN to participate in all the SLIPTA and SLMTA activities, including the 3 series of task-based training workshops which held at different times between 2010 and 2012. The Laboratory Manager and the Quality Assurance Officer were both sponsored to attend these trainings. APIN also sponsored the other staff of the centre to attend other trainings in quality management system (QMS) and other related accreditation trainings such as QMS Audit, Method Validation, Logistics Management of Health Commodities, ISO 15189, Statistical Quality Control, etc. To ensure that requirement of the QMS standards were met, APIN worked with the centre to develop their QMS documents including the quality manual and quality SOPs. APIN also periodically visited the laboratory to conduct internal audits, provide mentorship, supportive supervision, and technical assistance that helped the laboratory in their preparation for accreditation. APIN also supported not only the maintenance of diagnostic equipment, but also the maintenance and calibration of ancillary equipment used by the centre.

Annually, APIN organized a quality and accreditation conference where the performance of the centre, alongside other APIN-supported laboratories, were reviewed. During each of the conferences, APIN worked with centre to identify existing quality gaps and provided technical assistance on how to address them. At the baseline SLIPTA audit, the laboratory made 3 Stars, 4 Stars at the exit SLIPTA audit, and finally made 4Stars at the ASLM SLIPTA audit. As a result of this outstanding achievement, the centre was recommended by ASLM to apply for accreditation. APIN supported the payment of the accreditation assessment visit by the South Africa National Accreditation Scheme (SANAS) Prior to the accreditation visit by SANAS, APIN provided periodic on-site mentorship visit to the centre, working with them to address pending quality gaps, and sharing SANAS accreditation guidelines and requirements with management of the centre. Hared. Following the conclusion of the accreditation assessment by SANAS, APIN was also involved in helping the centre to resolving few identified nonconformities. Records of resolution of the assessment nonconformities were submitted to SANAS which were reviewed and found satisfactory, and for which the decision to accredit the centre was concluded.


BENEFITS OF LABORATORY ACCREDIATTION TO ISO 15189

  • Grants national and international recognition to the laboratory, since the standard is an internal standard.
  • Promotes public and customer acceptance; increases customer/public satisfaction, confidence and retention
  • Provides assurance to clients of good laboratory practice, and increases the reliance of decision makers on test results
  • Meets regulatory specifications, and ensures better support in the event of legal challenge.
  • Improves staff motivation, awareness and esteem, as well as creates an overall management and staff satisfaction.
  • Gives confidence to the laboratory for the results they generate.
  • Minimizes errors and risks, thereby reduces wastages and operating costs, while it increases productivity and savings.
  • Enhances the culture of quality by harmonizing practices.
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