Quality Assessment Manual


Book Description







Malaria Microscopy Quality Assurance Manual - Version 2


Book Description

The first version of the WHO Malaria microscopy quality assurance manual (2009) was based on recommendations made at a series of informal consultations organized by WHO particularly a bi-regional meeting of the WHO regional offices for South-East Asia and the Western Pacific in April 2005 in Kuala Lumpur Malaysia followed by informal consultations held in March 2006 and February 2008 in Geneva Switzerland. Subsequently extensive consultations among international malaria experts led to consensus and preparation of the manual. This second version of the Manual is based on the recommendations of experts made at a WHO technical consultation in March 2014 in Geneva Switzerland. The aim of the meeting was to review the experiences of national malaria control programmes (NMCPs) national reference laboratories (NRLs) and technical agencies in using the Manual and country experience in order to improve systems for managing the quality of malaria microscopy. This second version takes into account the many years of experience of several agencies in the various aspects of quality assurance (QA) described in the Manual. In particular the sections on assessment of competence in malaria microscopy are based on use of this method by the WHO regional offices for South-East Asia and the Western Pacific in collaboration with the WHO Coordinating Centre for Malaria in Australia and by the WHO Regional Office for Africa in collaboration with Amref Health Africa. The section on setting up and managing an international reference malaria slide bank is based on the work of the WHO Regional Office for the Western Pacific in collaboration with the WHO Coordinating Centre for Malaria Diagnosis in the Philippines. The section on proficiency testing for malaria microscopy is based on work in the WHO Regional Office for Africa in collaboration with the National Institute for Communicable Diseases in South Africa and experience in regional initiatives by Amref Health Africa. The section on slide validation is based on work by Médecins sans Frontières and the section on outreach training and supportive supervision (OTSS) is based on work by the President's Malaria Initiative Malaria Care Project Medical Care Development International and Amref Health Africa. The Manual is designed primarily to assist managers of NMCPs and general laboratory services responsible for malaria control. The information is also applicable to nongovernmental organizations (NGOs) and funding agencies involved in improving quality management systems for malaria microscopy. The Manual is not designed for QA of microscopy in research situations such as in clinical trials of new drugs and vaccines or for monitoring parasite drug resistance. It forms part of a series of WHO documents designed to assist countries in improving the quality of malaria diagnosis in clinical settings including the revised training manuals on Basic malaria microscopy (2010) and the Bench aids for malaria microscopy (2010).







Malaria Microscopy Quality Assurance Manual


Book Description

Early diagnosis and prompt, effective treatment is the basis for the management of malaria and key to reducing malaria mortality and morbidity. An acceptable microscopy service is one that is cost-effective, provides results that are consistently accurate and timely enough to have a direct impact on treatment. This requires a comprehensive and active quality assurance (QA) program. This manual outlines a hierarchical structure based on retraining, validation and the development of competency standards designed to ensure the quality of diagnosis necessary for a successful malaria program, while remaining within the financial and personnel resources likely to be available. The mode of implementation of the QA system outlined in this manual will vary according to the organization of the national laboratory services dealing with malaria, which may fall under the national malaria control program, or under a separate laboratory structure working closely with the malaria program.







Laboratory Quality Management System


Book Description

Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".







Handbook of Quality Assurance for the Analytical Chemistry Laboratory


Book Description

xii a second edition might be in order, and readily agreed. Although the basic principles remain the same, discussions with analysts, laboratory supervisors, and managers indicated many areas where improve ments could be made. For example, new chapters have been added on sampling and quality assurance; laboratory facilities and quality assurance; and auditing for quality assurance. Very little of the first edition has been discarded, but many topics have been expanded considerably. The chapter on computers has been completely rewritten in view of the rapid changes in that field. The chapter in the first edition on planning and organizing for quality assurance has been split into two chapters, one on planning for quality assurance and the other on organizing and establishing a quality assurance program, and new material on mandated quality assurance programs has been combined with the material on laboratory accreditation. Numerous examples, especially those involving mathematical calculations, have been added at the suggestion of some readers. In short, this edition is very nearly a new book, and I can only hope it is as well received as the first edition. CHAPTER 1 Quality, Quality Control, and Quality Assurance One of the strongest trends in modem society is the continuing ev olution from a manufacturing to a service-oriented economy.




Internal Audit Quality


Book Description

Deliver increased value by embedding quality into internal audit activities Internal Audit Quality: Developing a Quality Assurance and Improvement Program is a comprehensive and authoritative guide to better practice internal auditing. Written by a global expert in audit quality, this guide is the first to provide complete coverage of the elements that comprise an effective internal audit quality assurance and improvement program. Readers will find practical solutions for monitoring and measuring internal audit performance drawn from The IIA's International Standards for the Professional Practice of Internal Auditing, and complemented by advice and case studies from leading audit practitioners from five different continents. Major corporate and financial collapses over the past decade have challenged the value of internal audit. With an increased focus on internal audit's role in good governance, management is increasingly demanding that internal audit provides assurance of the quality of its own activities. The IIA standards provide a framework for audit quality in the form of mandatory guidance . Recent research indicates that the majority of internal audit functions do not fully comply with the standards and, as a result, are not servicing the needs of their organizations as well as they might. Internal Audit Quality offers a roadmap to internal audit quality, providing readers the guidance they need to: Embed quality into all elements of internal audit from strategic and operational planning down to day-to-day tasks Create well-defined internal audit programs and procedures Independently self-assess internal audit quality and performance Conform with the IIA standards and better practice Provide assurance over internal audit efficiency and effectiveness Deliver value by meeting stakeholder expectations As a key component of good governance, internal audit is on the rise. The days of retrospective, compliance-focused auditing is a thing of the past. Organizations expect more of internal audit, and many internal audit activities are accepting the challenge. Rather than relying on audit supervision and external assessments, modern auditors are embedding quality into audit activities to create effective programs. For the auditor looking to distinguish themselves as leading edge, Internal Audit Quality provides the guidance that enables the right work, at the right time, in the right way.