CERTIFICATION OF MEDICAL LABORATORIES (Institute for Medical Biochemistry of the Clinical Center of Serbia) Medical laboratories are important for the treatment of patients and for health care in general. They are operated in accordance with a doctor’s request, preparation of a patient, identification of a patient, sample taking, transportation, keeping, testing and analysis of samples, along with the appropriate validation, interpretation, reporting and with the opinion from laboratory if required, with the assurance of quality work and ethical conduct in the medical laboratory work. In order to achieve the aforesaid, appropriate education of the staff is necessary. The application of external quality inspection in clinical biochemical laboratories has induced the need for implementation and certification of the quality management system and accreditation in these and other medical laboratories. In 1950 the first biochemical laboratory was opened at the Medical Faculty in Belgrade. In 1952, at the Internal B clinic, thirteen graduated pharmacy students formed the CENTRAL CLINICAL LABORATORY as the precursor of the today's Institute for Medical Biochemistry of the Clinical Center of Serbia. The Central Clinical Laboratory made huge contribution in the development of the biochemical service and medical biochemistry as a new health sector in our country. Above-mentioned graduated pharmacists played a major role in forming biochemical laboratories at the clinics and institutes of the Medical Faculty in Belgrade. On 10 October 1987 a new powerful laboratory at the policlinic of the University Clinical Center was formed and on 1 December 1987 a laboratory in the emergency center of the same center was formed. These laboratories at that time created clinical-biochemical service at the University Clinical Center and in 1991 all other clinical-biochemical laboratories were attached to this service. With this merger in 1992 the INSTITUTE FOR MEDICAL BIOCHEMISTRY (IMB) of the Clinical Center of Serbia was formed. In this way a professional-methodological and reference center for the area of clinical-biochemical diagnostics was established. It made important contribution in implementing modern diagnostics in our country, in standardization, unification and workflow control in every laboratory in the country. During its development and presence, with huge enthusiasm, responsibility and ardency of all employees, the institute now successfully fulfills the following activities: Health activity, i.e. clinical-biochemical laboratory diagnostics as routine and highly specialized with the analysis of all available biological material. Over 500 clinical biochemical compounds from every field of medical biochemistry were analyzed at the institute. Six million analyses are run annually. With knowledge and skills, experts of the institute have enabled introduction of the modern clinical-biochemical laboratory diagnostics for the needs of all areas of medicine, which are practiced at the Clinical Center of Serbia. Scientific and research activity in cooperation with every institute of the Clinical Center of Serbia and other affiliate institutions, which produced numerous thesis by Masters of Science and Doctors, as well as specialist and subspecialist papers for the Clinical Center of Serbia, the Medical and Pharmaceutical Faculty and other affiliate institutions. Such cooperation led to publishing various scientific papers, as well as participation at the national and international meetings of the experts from the above mentioned institutions, which are jointly presented in the annual journals of the Clinical Center of Serbia and scientific projects financed by the Ministry for Science and Technology. Educational activity is the tutoring base of the Pharmaceutical and Medical Faculty and other affiliate faculties and schools. Students of all sections learn about new techniques, practices and methods in the field of laboratory medicine. In this way, the institute is a genuine education center for the field of medical biochemistry. Professional-methodological activity is performed by the institute as the referent institution in Republic of Serbia. Experts of the Institute for Medical Biochemistry have participated in the making of all published professional-methodological guidebooks for the filed of medical biochemistry on the level of the Republic and Ministry of Health. Together with the Serbian Society of Medical Biochemistry, the institute is organizer of the external quality assessment (YUNEQAS) as well as surveillance over the expert workflow in the laboratories in Republic of Serbia. External quality assessment is implemented as the unique measure in our health system, which enables continual progress of workflow of all clinical-biochemical laboratories in Serbia, contributes high precision of the laboratory services, eliminates unnecessary repetitions of this type of diagnosis and reduces expenses and costs. With the decree of the Ministry for Labor, Health and Social Politics, the Institute for Medical Biochemistry is in charge of assessment and control of the quality of diagnostic resources, thus allowing state administration to ensure import of quality material only. Other activities. The Institute for Medical Biochemistry is the organizer of expert and scientific manifestations, and the experts of this institute are members of numerous commissions and associations in the country and abroad. The institute for Medical Biochemistry with this activity provides and implements standard procedures of workflow in the diagnosis as well as forming of protocol and implementing uniformed organization of work-flow in all laboratories in the country. Implementing quality management system in laboratories of the institute. In order to improve work-flow and maintain quality of services, the Institute for Medical Biochemistry of the Clinical Center of Serbia has introduced a quality management system according to the ISO 9001:2000 standard, and afterwards has received accreditation for all laboratories in the field of diagnosis, in order to serve its users - doctors and patients. Upon implementing all necessary activities, the Institute for Medical Biochemistry of the Clinical Center of Serbia has received on 7 February 2001, the ISO 9001:2000 certificate, Reg. No. 080, by YUQS, the Organization for Quality Systems Certification, which confirms that the whole institute has established a quality management system. The certificate refers to the following areas of workflow: medical biochemistry, clinical-biochemical laboratory diagnostics, external quality assessment programme and testing of diagnostic means - reagents and equipment. In November 2001, the institute for Medical Biochemistry has received from the Yugoslav Accreditation Body JUAT (now Serbian Accreditation Body ATS), the decision on accreditation of all laboratories, which confirms that this institute is competent for implementing activities according to modern principles of workflow concerning organization and methodology of workflow. Aims of the implementation of the quality management system at the institute are defined in the Quality Policy and Declaration on Quality Politics. Declaration on Quality Politics has clearly defined outset for establishing and implementing a quality management system. It is consisted of aims and basic principles of the Institute for Medical Biochemistry of the Clinical Center of Serbia and describes ways of fulfilling aims and principles of the workflow based on good laboratory practice. The quality management system is fulfilled by the institute for Medical Biochemistry of Clinical Center of Serbia in a way that it respects the principles of being oriented toward users - doctors and patients, providing quality and timely services in: - informing and developing - following development of clinical-biochemical diagnostics - establishing modern and efficient methods of research - precise and timely findings, which is achieved with proper organization and technology of work-flow - efficient flow of biological material - good analytical workflow and data flow The institute has established this system by resources management as well (staff, equipment, consumables, providing conditions of the working atmosphere - hygiene and tidiness of the premises, regular health checks of the employees, usage of the protective equipment, safety regulations application) and the management of the workflow processes (support of the defined work technology, implementing of the new research method.) The laboratory research is in compliance with the documents of the quality management system, which is consisted of reception of request, reception of samples, taking of the sample in the laboratories of the institute, triage of the biological material, handling with the samples, issuing results and communication with doctors and patients (clients). Measurement and support for the development of the quality management system is performed according to the request of the standard - by analysis of the data and information and continual improvement of the workflow. In the instruction Measurement of the level of the customer satisfaction it is precisely defined: - Quality of the service, i.e. accuracy of the research result - Date of issue of the result - Capability of laboratory to stand up to urgent demands, which are parameters for assessing users' satisfaction (doctors and patients). Measurement and surveillance of the processes at the institute comprises constant supervision and activity control of the research, supervision and control of the chemicals and equipment that are used in research, internal workflow control, international external workflow control (RIQAS control) and national workflow quality control. All methods that are used during work-flow, as well as documents and instructions on handling and running the equipment, are precisely described. It can be concluded that the implementation of the quality management system has provided the following benefits for the institute: 1. Good communication and cooperation with the clients (doctors and patients) 2. Precise implementation of the defined workflow technology 3. Efficiency in workflow through overall planning of the activities and resources 4. Optimum exploit of the current capacity and fulfilling tasks 5. Accuracy of workflow in every phase of the laboratory process 6. Accuracy of results of the laboratory research as an imperative 7. Good communication between all categories of workers and managing structures 8. Good communication with expert services of the Clinical Center of Serbia 9. Timely answer to complaints on quality of service This means that the implementation of the quality policy and quality system documents for the Institute for Medical Biochemistry contributes to the complete fulfillment of its tasks in difficult circumstances and provides security for the users concerning quality of the services delivered. All mentioned activities are fulfilled with exceptional commitment of all employees at the Institute for Medical Biochemistry. It can be concluded from the presented facts that through all its activities this institute is dedicated to providing good and timely laboratory diagnostics, as an important factor in the diagnostics and treatement of the patient.