This document presents a strategic framework, aimed towards the development of sustainable global, regional and national plans relating to laboratory biorisk management.
SOP- Quality Assurance of Malaria Diagnostic Tests
Int J Crit Illn Inj Sci. 2012 May-Aug; 2(2): 82–97.
doi: 10.4103/2229-5151.97273
PMCID: PMC3401822
PMID: 22837896
This resource consists of technical guidelines for District Medical Officers, counselors and laboratory technicians for second-line antiretroviral therapy drugs, operational guidelines for pilot roll-out in two centres and laboratory guidelines for viral-load testing and standard operating procedure...s.
more
The National Tuberculosis Programme (NTP) of Rwanda (known as TB & ORD Division/IHDPC/RBC) is preparing to write their next National Strategic Plan and for this reason Rwanda was selected as a country to received technical assistance (TA) to conduct an assessment of their surveillance system using t...he surveillance checklist as input for the new strategy. This TA was provided under the USAID TBCARE I Core project on Monitoring and Evaluation, Operational Research and Surveillance (C7.08) developed a surveillance checklist with the objectives to assess a national surveillance system’s ability to accurately measure TB cases and deaths and to identify gaps in national surveillance systems that need to be addressed in order to improve TB surveillance.
more
National Tuberculosis Programme and Senior Paediatricians
This guideline was first developed in 2007 but further updated in 2012 and 2016 to ensure the use of the latest evidence-based international recommendations on childhood TB. The guidelines will fill the gaps in a systematic approach to T...B in children and will help to achieve an internationally recommended standard of care at all levels of the health system in Myanmar.
more
A manual for health care providers.
This manual provides expert guidance on the laboratory techniques and procedures used in the diagnosis of Buruli ulcer, a disease caused by Mycobacterium ulcerans. Aimed at laboratory technicians and scientists working on this disease, the manual details the exac...t procedures to follow when performing a range of diagnostic tests. Recommended procedures, intended for use throughout the health system, are presented at levels appropriate for peripheral, district and central services and in accordance with the varying resources, skills and equipment typically found in countries where Buruli ulcer is endemic.
more
The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
more
The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. These guidelines include laboratory design considerat...ions, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.
more
This document provides guidelines and tools for monitoring the quality of outsourced viral load test results in India, defining processes and procedures as well as quality indicators and a monitoring checklist for assuring quality of services. Annexes include reporting forms and checklists for monit...oring visits.
more
The major areas of focus for the plan will be:
- Social mobilization and community empowerment (health promotion & education for disease prevention);
- Promotion of access to safe water, good sanitation and hygiene;
- Surveillance and laboratory confirmation of outbreaks;
- Prom...pt case management and infection control;
- Complementary use of oral cholera vaccine (OCV) for cholera endemic communities; and
- Coordination and stewardship between and for all actors.
- Monitoring, supervision, evaluation and operation research to ensure continued improvement in service delivery.
more
The 6th edition of the essential medicine list has been developed based on the 5th edition list of essential medicines, the National Standard Treatment Guidelines and Protocols 2013, list of laboratory commodities and List of Consumables used in public health facilities.
This document sets out the preparedness and response plan of the Nigerian Primary Health Care System for COVID-19 Acute Respiratory Disease. It outlines the planning scenarios, key areas of work and priority activities required for the Primary Health Care Sector to quickly scale up its core capacity... to prevent, quickly detect, characterize and efficiently respond, in a coordinated manner to the COVID-19 pandemic. These include guidelines for the setup and operationalization of COVID-19 response platforms at the national and state levels, guidelines for the provision of PHC services during the pandemic to minimize transmission in PHCs as well as guidelines for preparedness and response of PHC Centres and communities for COVID-19 case detection and response.
more
There is a crucial need to initiate and sustain fistula programs that increase access and strengthen the capacity of the health care system to provide high quality services for repair and care of women living with female genital fistula. Therefore, it is important to pay particular attention to the ...quality of training, and to proactively determine how this training fits into the health care system. Furthermore, the quality of training is improved by committing adequate resources to ensure competent trainers, able to train and follow-up their trainees. Women with genital fistulae, their families and the community need to have confidence in the health care system. It is therefore necessary to have pro-active discussions about the quality of training with relevant stakeholders. These fistula training guidelines and standards go towards harmonizing the training approach and to improving the quality of training and hence, service delivery.
more
FAO and WHO jointly developed a comprehensive tool to assist Member states in assessing the effectiveness of national food control system. The FAO/WHO Food Control System Assessment Tool comprises 162 assessment criteria under 25 system competencies over 4 Dimensions. This introductory booklet is de...veloped to facilitate application of the assessment tool.
more
Este instructivo se aplica a la implementación del SNVS 2.0 para la notificación de pruebas rápidas para sífilis, vih y/o hepatitis b y c; en los puntos de atención para personas usuarias del sistema de salud. Éstos pueden ser centros de salud del primer nivel de atención, locales o espacios ...que brindan las organizaciones de la sociedad
civil, campañas en la vía pública, espacios educativos, etc. No necesariamente refiere al contexto de los laboratorios convencionales. Se caracterizan por la devolución rápida del resultado a la persona testeada y la posibilidad de tomar una decisión oportuna de inciar un tratamiento y/o proponer medidas preventivas.
more
The WHO BioHub Biosafety & Biosecurity: criteria and operational modalities sets out the requirements to which laboratories wishing to receive biological materials as part of this international exchange system should abide, to ensure safe and secure operations. These provisions are in accordance wit...h the recommendations of the WHO Laboratory Biosafety Manual 4th edition (LBM4), adopting an evidence- and risk-based approach to enable scalable and adaptable biosafety provisions and actions, proportionate to the assessed risk
more
Maternal mortality has fallen significantly in recent years, especially in countries that have emphasized the prevention of its main causes, such as hemorrhagic and infectious complications and hypertension , including in the Region of the Americas. In its final report on the Plan of Action to Accel...erate the Reduction of Maternal Mortality and Severe Maternal Morbidity, the Pan American Health Organization (PAHO) reported a continuing downward trend in maternal mortality, with an 18.1% reduction in the maternal morbidity ratio during the period 2010-2015 . From a pathophysiological perspective, death events are a common end result of a wide spectrum of complications leading to multi-organ dysfunction. However, there is a group of women in this situation who survive, despite the seriousness of their condition. This high number of patients––who were in serious condition
but did not die––reflects the actual health conditions in an institution or a country. For this reason, there is a need to create indicators to estimate morbidity in women due to diseases and incidents that occur during pregnancy, childbirth, and the puerperium. To this end, we propose conducting epidemiological surveillance of an indicator that includes women who survived after presenting a potentially fatal complication during pregnancy, childbirth, or the puerperium, reflecting quality medical attention and care (5, 6). This indicator
is maternal near-miss (MNM), which refers to extremely severe maternal morbidity––cases of a severity that
brings women very close to the death event. After adjusting the definition to a specific population and time,
MNM is defined as a case in which a woman nearly died, but survived a complication that occurred during
pregnancy, childbirth, or within 42 days of termination of pregnancy
more