scholarly journals Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory – Mwanza, Tanzania

2018 ◽  
Vol 7 (1) ◽  
Author(s):  
Medard Beyanga ◽  
Lisa Gerwing-Adima ◽  
Kahima Jackson ◽  
Benjamin Majaliwa ◽  
Henrico Shimba ◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Clinical Laboratory ◽  
Medical Centre ◽  
Iso 15189 ◽  
Bugando Medical ◽  
Bugando Medical Centre

scholarly journals Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research

2019 ◽  
Vol 3 ◽  
pp. 137 ◽  
Author(s):  
Horace Gumba ◽  
Joseph Waichungo ◽  
Brett Lowe ◽  
Alfred Mwanzu ◽  
Robert Musyimi ◽  
...  
Keyword(s):  
Quality Management ◽  
Medical Research ◽  
Management System ◽  
Quality Management System ◽  
Clinical Laboratory ◽  
Research Programme ◽  
Good Clinical Practice ◽  
Laboratory Practice ◽  
Laboratory Personnel ◽  
Middle Income

Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of GCLP at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.

Development of quality management system documents of medical laboratory in accordance with the requirements of ISO 15189:2012

2016 ◽  
pp. 14-17
Author(s):  
A.V. Emanuel ◽  
A.V. Kalenskaya ◽  
G.A. Ivanov ◽  
A.V. Avramenko ◽  
N.A. Zimakova ◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Medical Laboratory ◽  
Iso 15189

scholarly journals Practical Guidance for Clinical Microbiology Laboratories: Implementing a Quality Management System in the Medical Microbiology Laboratory

2018 ◽  
Vol 31 (3) ◽  
Author(s):  
Roberta B. Carey ◽  
Sanjib Bhattacharyya ◽  
Sue C. Kehl ◽  
Larissa M. Matukas ◽  
Michael A. Pentella ◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Daily Practice ◽  
Microbiology Laboratory ◽  
Iso 15189 ◽  
Laboratory Staff ◽  
Roles And Responsibilities ◽  
Technical Requirements ◽  
Total Testing Process

SUMMARY This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement. The roles and responsibilities to establish and sustain a QMS are outlined for microbiology laboratory staff, laboratory management personnel, and the institution's leadership. Examples and forms are included to assist in the real-world implementation of this system and to allow the adaptation of the system for each laboratory's unique environment. Errors and nonconforming events are acknowledged and embraced as an opportunity to improve the quality of the laboratory, a culture shift from blaming individuals. An effective QMS encourages “systems thinking” by providing a process to think globally of the effects of any type of change. Ultimately, a successful QMS is achieved when its principles are adopted as part of daily practice throughout the total testing process continuum.

scholarly journals Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research

2018 ◽  
Vol 3 ◽  
pp. 137 ◽  
Author(s):  
Horace Gumba ◽  
Joseph Waichungo ◽  
Brett Lowe ◽  
Alfred Mwanzu ◽  
Robert Musyimi ◽  
...  
Keyword(s):  
Quality Management ◽  
Medical Research ◽  
Management System ◽  
Quality Management System ◽  
Clinical Laboratory ◽  
Research Programme ◽  
Good Clinical Practice ◽  
Laboratory Practice ◽  
Laboratory Personnel ◽  
Middle Income

Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of Good Clinical Laboratory Practice (GCLP) at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.

Implementation and monitoring of a quality management system based on the standard UNE-EN-ISO 15189 in a urine culture unit

2012 ◽  
Vol 45 (4-5) ◽  
pp. 374-377 ◽  
Author(s):  
María-Fe Bautista-Marín ◽  
María-Dolores Rojo-Martín ◽  
Mercedes Pérez-Ruiz ◽  
Consuelo Miranda-Casas ◽  
Purificación Martínez-Muñoz ◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Urine Culture ◽  
Iso 15189

scholarly journals Review and comparison of quality standards, guidelines and regulations for laboratories

2011 ◽  
Vol 1 (1) ◽  
Author(s):  
Tjeerd A.M. Datema ◽  
Linda Oskam ◽  
Paul R. Klatser
Keyword(s):  
Quality Management ◽  
Low Income ◽  
Management System ◽  
Quality Management System ◽  
Clinical Laboratory ◽  
National Laboratory ◽  
Quality Standards ◽  
Ethical Behaviour ◽  
Clinical Quality ◽  
Almost All

Background: The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system. Objectives: There is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories. Method: We reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services. Results: Differences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents. Conclusion: Each laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.

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