Quality Management Systems in Laboratories
Introduction.
My previous experience as responsible for quality and specialization studies would allow me work methodology and the most important within a clinical laboratory. This experience gives me opportunities to develop organization skills, planning, monitoring, control, leadership, etc.
My labor link begins in 2012 until the first months of 2016 in the area of bacteriology, developing intervention projects, focused on improving capacities in Latin America laboratories. The Laboratory Improvement Program of the Military Forces in Latin America- Promale was a program that provided quality management assistance, followed by a series of monitoring and technical training activities, with the aim of bringing laboratories closer to standardization and implementation of the international ISO 9001 standard, as the first step towards a future accreditation based on ISO 15189: Clinical-particular clinical laboratories for quality and competition, specific for its application in clinical laboratories.
Developing.
The program was funded by the "Emergency Plan of the United States Presidency for the fight against AIDS (Pepfar)", through the "HIV / AIDS Prevention Program of the United States Department of Defense (DHAPP)" " and the Namru-6. Promale, was born in 2012, and was a joint effort of institutions such as the “United States disease control and prevention centers (CDC)”, CDC-DR (Dominican Republic Office), CDC-GT (Regional Office of the Regional Office of Central América), Find (“The Foundation for Innovative New Diagnostics”) and Commission (Council of Ministers of Health of Central America), with the aim of strengthening and promoting sustainability quality management in laboratories of the entire work network in Latin America.
Promode, a program created to optimize the reliability and quality of the services provided by laboratories of Central America, the Caribbean and South America, for research in diseases of importance in public health. With a special approach to HIV, STIs and tuberculosis, we were the only work team in carrying out this intervention. Being the opportunity to present the work done and its results in conferences and scientific meetings.
Considering necessary to establish the component of “strengthening” of laboratory competencies, training for laboratory personnel also begins, so that their technical skills can be strengthened and to improve the service provided to its members and relatives. This experience allowed me to contribute and work on issues related to quality, management and security, interacting and sharing experiences with teams of great experience and establishing objectives with common interests in the region for public health.
Until today, rules and regulations have been created whose purpose is to order and standardize the procedures and parameters in terms of quality. In developing countries and due to different realities, the result can be affected, such as: the shortage of capacity in personnel, the allocation of limited budgets, the lack of progress and modernization, poor maintenance of physical infrastructure and shortage of reagents and supplies.
There is a need to provide a basis for laboratory management and strengthening, as an integral health part in general (15). Laboratories intervene in 70% of medical processes, and is essential for patient safety, through the control and assurance of each of these phases of the laboratory cycle. Estimated errors of up to 75% and even other authors consider up to 85% during the pre-analytical stage where the highest percentage of errors related to laboratory tests occurs, and if it is also considered that 12.5 % erroneous results can lead to importance as part of the medical decision -making process.
The current national regulations of Peru define and provide guidelines, establishing quality standards necessary to guarantee an adequate process and manipulation of laboratory clinical samples, there are usually too many deficiencies and the need to forge or implement a quality management system is urgent since The great demand for user dissatisfaction needs it, ensuring the quality and safety of the results.
In addition to the development of technology and new forms of diagnosis, they are needs of modernization, required to laboratories for the fulfillment of new quality challenges, functions and responsibilities; The shortage of resources and infrastructure, in order to properly carry out the processing of the samples, the low availability of the human resource is also a great limiting and in turn the lack of protocols and standards that make the process of traceability of samples poor.
Clinical laboratories have a leading role, due to the emergence of new epidemics. The timely response capacity of laboratories is necessary providing exact and precise, specific and comparable results with those of another; these characteristics being obvious are becoming complex requests or characteristics when considering its compliance. Failures from pre -analytical processes to the release of the results that affect the provision of diagnostic services are recognized as the main objectives for quality improvement, this should lead to preventive and corrective actions.
There are publications and articles where the causes and circumstances that affect the performance and accessibility of laboratories to the supply of materials, essential equipment, trained personnel, etc.; However, despite its relevance as information generators for the treatment and monitoring of diseases, this is not treated or developed progressive improvement plans.
This problem has been observed in laboratories that participate in programs and control strategies whose millionaire funds contribute to the world’s fight against great epidemics such as HIV / AIDS, malaria and tuberculosis, being affected by the lack of reliability in their results, added to High demand limits the contribution of clinical data for surveillance and control purposes on public health problems (23-25). According to the publication of the Inacal website: Ministry of Health and National Superintendence of Health, while the National Quality Institute “only 10% of clinical laboratories in Peru offers reliable results.
“The results realize that only 10% of these establishments operate with systems based on processes and quality management systems, 84% do not know the accreditation standard applicable to its item NTP-ISO 15189 that allows reliable results, 90% of clinical laboratories do not make quality assurance, while 92% do not know or do not use the metrology services of companies or institutions accredited by Inacal that allows ensuring the calibration of the clinical instruments or equipment they use.
The implementation and certification of ISO 9001 in clinical laboratories begins in Peru in mid -2005. Currently in Peru, there are regulatory entities and are regulatory, to their application for example inacal, being the issuance of its voluntary compliance standards. It is in this sense that the importance of ensuring quality in laboratories management is increasingly Within laboratories, contributing to the improvement of services and patient safety.
Additionally, the participation of laboratories in proposition programs or inter-labor controls, allow improving the performance, reproducibility and accuracy of the laboratory results, being able to demonstrate their equivalence to recognized and accepted standards, as is the set of ISO standard , demonstrating that it can always produce with the same quality.
In relation to quality management systems, it begins with the issuance of the Technical Health Standard of the Clinical Pathology Services Production Unit (NTP N ° 072 MINSA-DGSP-V.01- Ministry of Health), of 2009, to improve the quality of care in public and private services, regulating criteria of organization, management and operation, having as a bibliographic consultation the ISO 15189: 2004 medical laboratories, on requirements on requirements on requirements individuals for quality and competence.
At present, the Peruvian Technical Standard NTP-ISO 15189: Medical Laboratories, on particular requirements for quality and compete by the Nationalization-National Institute of Defense of Competition and the Protection of Intellectual Property (INDECOPI) in 2004 and there are already the version of the year 2008 and currently the current one of 2014.
Conclusions.
In recent years and for the growth in the demand for access to health services worldwide, the number of laboratories that not only are part of public services has been increased, but also as part of private supply, what that has increased the degree of competitiveness, without there is so far defined conditions for the control and supervision of the necessary work, promoting a growing distrust in terms of the truthfulness and certainty of the results offered.
The improvement must be a priority within the strengthening of health systems and that is why identifying this globalized need in countries with limited resources organizations and institutions of governments are seeking support mechanisms in development and improvements within laboratories and other areas They support health services. And at present, "quality" is a mandatory added value in health services.
The tendency of the "implementation of an SGC", until obtaining a certification or an accreditation has been growing for some years and is being supported by the development of policies that lead to strengthening the abilities of laboratory staff. It is a fact that there is also a desire to take this opportunity as a platform to improve the structure, organization and operation of laboratories.
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