Our Lady of Lourdes Mutomo Hospital’s laboratory has established a quality system to strengthen its testing capabilities with the goal of becoming accredited to the ISO 15189 standards. The ISO 15189 accreditation encompasses the following laboratory operations:

  1. Documents and Records

  2. Management Reviews

  3. Organization and Personnel

  4. Client Management and Customer Service

  5. Equipment

  6. Internal Audits

  7. Purchasing and Inventory

  8. Process Controls

  9. Laboratory Patient Information Management

  10. Corrective Actions/Preventative Actions

  11. Occurrence/Incident Management and Process Improvement

  12. Facilities and Bio-safety

The BD-PEPFAR program has assessed the laboratory’s ISO15189 accreditation progress through a5-star rating scale Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist. 

  • The baseline SLIPTA assessment performed in August 2015 identified key opportunities for improvement.

  • During the first BD mentorship supported by Susan Merrill and Abdirizack Ahmed in January 2016, the laboratory developed a laboratory quality manual, bio-safety manual, established quality control processes and identified quality indicators.

  • The second mentorship (13th – 30th June 2016) has just successfully been completed. The laboratory staff facilitated by Adilene Dominguez and Manju NJ has showed their continuation of ongoing activities by developing over 90 Standard Operating Procedures, performing internal and safety audits, mastering document control, establishing an equipment/method validation program, and complying with infection control standards.

The fourth mentorship took place from February 6th through the 23rd of 2017. Pamela Brion and Steve Knapp worked with the laboratory team to perform assessments and complete the following activities:

  • Improving Specimen flow process through upgrading Visual management 

  •  Trainings on various Processes (Risk assessment, CAPA, Calibration, Validation, etc.) 

    We trust that our continued hard work will get us to the accreditation level.

  •  Developing a pathway for Continuous improvement through Quality Indicators, Charts and Analysis

  • Creating, Approving  and training  more than 25 SOPs and Forms

  • Creation and revision of 10 standard operating procedures

  • Continued work on method verification and validation started by previous mentors by providing additional training, protocol/report templates, data analysis templates and performing a precision and reproducibility study for a laboratory electrolyte test

  • Implemented an updated procedure and performed training on the management review process and internal audits

  •  Performed training on the use of control charts for monitoring QC data from laboratory tests

  •  Developed scheduling for internal audits and equipment maintenance

  •  Refresher training on the CAPA process and patient confidentiality

The fifth mentorship program took place from June 20th, 2017 to July 6th, 2017, facilitated by Jorge de Freitas and John Simpson.  The main objective was to work with the laboratory staff to “strengthen the foundation” to achieve accreditation. 

The following were accomplished:

  1. Previous action items including calibration and installation of equipment, facility improvements

  2. Documentation – organization of SOPs, update of quality manual and SOPs, and other forms to comply with ISO.

  1. Training – Good Documentation Practice, Risk Management/Risk Assessment, Bio-Safety, Internal Audit, Electronic Document/File Management, Inventory and stock control

  2. Quality Improvement – Development of Work – Aids

 We are grateful to the laboratory staff for their dedication and commitment towards the accreditation process. 

The bar-chart demonstrates the steady progression towards accreditation.

We applaud our laboratory staff for their great accomplishments and ambitious aim of obtaining 5-stars.