ABSTRACT
Background@#Poor laboratory quality can lead to misdiagnosis and inappropriate treatment of patients. To demonstrate the quality and reliability of their services, medical laboratories seek accreditation to ISO 15189. We have initiated a project to assist laboratories in their efforts to obtain the accreditation. @*Goal@#Conduct a gap analysis of the status of preparedness of medical laboratories for accreditation.@*Materials and Methods@#Six laboratories are selected for participation in the project. In the first phase of the project, a gap analysis of the participant laboratories is conducted using an Excel program based on ISO 15189 requirements.@*Results@#The findings reveal that the participant laboratories are the strongest in Organization and management of laboratory, Quality of examination results, Personnel and facility management and in Laboratory information management. The majority of the laboratories are hospital based, and their organization and management are well established and functional mostly due to centralized administrative guidance. The concept of quality control is effectively adapted in medical laboratories, therefore ensuring the quality of examinations and the data management are usually in line with the requirements. Weaker areas include Evaluation and audits, and Document control. Even though the laboratories do conduct evaluations and control, they do not do it regularly and, most importantly, do not keep records routinely, which cause the higher gap rate.@*Conclusion@#Policies to meet ISO 15189 requirements are in place in the participant laboratories, but their documentation and records keeping are insufficient.
ABSTRACT
Rationale: Effective healthcare starts with an accurate diagnosis, and laboratory plays an important role in this. All health laboratories, be it clinical, animal health, food safety, or environmental health laboratory, contribute to health care and public health security. Therefore, many public health programs are conducting laboratory assessments. The assessment findings can be used for identification of areas in which efforts should be directed in order to strengthen the national laboratory system and health laboratories. Goal: The goal of the project was to assess the national laboratory system and health laboratories of Mongolia. Methods and materials: Laboratory assessment tool (LAT) developed by WHO was used for the assessment of two areas: 1. strategic organization at the national level, and 2. specific technical capacities at the laboratories level. The national laboratory system was assessed using LAT System questionnaire with the participation of MOH officers, and the assessment of laboratories was conducted using LAT Facility questionnaire with the involvement of laboratories representing public and private sectors, all three levels of urban and rural health care organizations, and clinical and public health areas of laboratory services. Results: The strongest areas of the national laboratory system at the policy and regulatory level were “Coordination and management” and “Laboratory information system”. The weaker (below 75%) areas were “Structure and organizations”, “Regulations”, “Infrastructure” and “Human resources”. The insufficient infrastructure score was due to the lack of financing. The main problems detected in the area of Human resources were insufficient financial and organizational support of continuous education of laboratory workers, shortage of trained personnel and incomplete national registration system of laboratory professionals. The results of the laboratory capacities showed that the assessed laboratories were strong in “Data and information management”, “Specimen collection and handling” and “Consumables and reagents”. The testing performance of most laboratories was excellent but the external quality assurance was not available in some test disciplines. The weaker areas of the laboratories were “Facilities”, “Public health functions” and “Biorisk management”. The module “Organization and management” showed lower score mainly due to insufficient budget. The same was with “Facilities”. Although the general safety management of laboratories was very good, the biosafety component was not incorporated in it. Conclusions and recommendations: 1.A national regulatory body needs to be established for the registration of all laboratories and laboratory professional staff. 2.Each laboratory should formally designate an appropriately trained Quality manager, 3.Set-up a formal professional development/ continuous education system for laboratory professionals. 4.Develop biosafety policy and implementation plan. 5.Establish a comprehensive national laboratory information management system (LIMS).
ABSTRACT
Background: In our country the thyroid diseases usually diagnosed using only laboratory indicators of thyroid hormons such as T3, T4, TSH and medical symptom. It means there are considerably late diagnosing of thyroid failure. In recently hypothyroidism and hypothyroidism are being diagnosed by specific thyroid antibodies which are instead during thyroid disorders in the worldwide. Although this diagnostic method is used in some laboratory in our country but their diagnostic significance have not yet been determined. It is important to lunce diagnostic methods for thyroid antibodies specially essential for endocrine doctors. Objective: To determine the diagnostic significance of thyroglobulin antibody and thyroid peroxidase antibodies in relation with thyroid disease. Research materials and methods: In this research of thyroid peroxidase antybody and thyroglobulin antibody, we use 20-64 age 23 patients who have hypothyrodism diagnostics, 36 patients how have hyperhotyrodism diagnostics, 30 patients who are relatively healthy and their disease was denied on symptom and laboratory test, total 89 people. Results: There were 57 female and 32 male from total 89 people investigated for this study. The traditional determination of thyroid hormones for diagnosis of thyroid diseases still have high diagnostic significance. The newly launched and used in our study anti-TPO and anti-Tg have very high significance for thyroid diagnosis. We found that anti-TPO antibody has primary information indicator and anti-Tg antibody is secondary information indicator for the diagnosis of thyroid disorder. Conclusion: 1.Among 59 patients with thyroid diseases 89.8% (n=53) of them determined increased anti-TPO concentration and 61% (n=36) of them increased anti-Tg concentration. It shows increase of these antibodies have high diagnostic significance for thyroid diseases. 2.For hyperthytiodism the anti-TPO has strong supportive information indicator (карра=0,64) and anti-Tg has primary information indicator (карра=0,84). 3.For hypothytiodism the anti-TPO has primary information indicator (карра=0,78) and anti-Tg has weak supportive information indicatot (карра=0,24).
ABSTRACT
Rationale: Effective healthcare starts with an accurate diagnosis, and laboratory plays an important role in this. All health laboratories, be it clinical, animal health, food safety, or environmental health laboratory, contribute to health care and public health security. Therefore, many public health programs are conducting laboratory assessments. The assessment findings can be used for identification of areas in which efforts should be directed in order to strengthen the national laboratory system and health laboratories.Goal:The goal of the project was to assess the national laboratory system and health laboratories of Mongolia.Methods and materials:Laboratory assessment tool (LAT) developed by WHO was used for the assessment of two areas: 1. strategic organization at the national level, and 2. specific technical capacities at the laboratories level. The national laboratory system was assessed using LAT System questionnaire with the participation of MOH officers, and the assessment of laboratories was conducted using LAT Facility questionnaire with the involvement of laboratories representing public and private sectors, all three levels of urban and rural health care organizations, and clinical and public health areas of laboratory services. Results: The strongest areas of the national laboratory system at the policy and regulatory level were “Coordination and management” and “Laboratory information system”. The weaker (below 75%) areas were “Structure and organizations”, “Regulations”, “Infrastructure” and “Human resources”. The insufficient infrastructure score was due to the lack of financing. The main problems detected in the area of Human resources were insufficient financial and organizational support of continuous education of laboratory workers, shortage of trained personnel and incomplete national registration system of laboratory professionals.The results of the laboratory capacities showed that the assessed laboratories were strong in “Data and information management”, “Specimen collection and handling” and “Consumables and reagents”. The testing performance of most laboratories was excellent but the external quality assurance was not available in some test disciplines. The weaker areas of the laboratories were “Facilities”, “Public health functions” and “Biorisk management”. The module “Organization and management” showed lower score mainly due to insufficient budget. The same was with “Facilities”. Although the general safety management of laboratories was very good, the biosafety component was not incorporated in it.Conclusions and recommendations:1.A national regulatory body needs to be established for the registration of all laboratories and laboratory professional staff.2.Each laboratory should formally designate an appropriately trained Quality manager, 3.Set-up a formal professional development/ continuous education system for laboratory professionals. 4.Develop biosafety policy and implementation plan.5.Establish a comprehensive national laboratory information management system (LIMS).
ABSTRACT
Background:In our country the thyroid diseases usually diagnosed using only laboratory indicators of thyroid hormons such as T3, T4, TSH and medical symptom. It means there are considerably late diagnosing of thyroid failure. In recently hypothyroidism and hypothyroidism are being diagnosed by specific thyroid antibodies which are instead during thyroid disorders in the worldwide. Although this diagnostic method is used in some laboratory in our country but their diagnostic significance have not yet been determined. It is important to lunce diagnostic methods for thyroid antibodies specially essential for endocrine doctors.Objective:To determine the diagnostic significance of thyroglobulin antibody and thyroid peroxidase antibodies in relation with thyroid disease.Research materials and methods:In this research of thyroid peroxidase antybody and thyroglobulin antibody, we use 20-64 age 23 patients who have hypothyrodism diagnostics, 36 patients how have hyperhotyrodism diagnostics, 30 patients who are relatively healthy and their disease was denied on symptom and laboratory test, total 89 people.Results:There were 57 female and 32 male from total 89 people investigated for this study. The traditional determination of thyroid hormones for diagnosis of thyroid diseases still have high diagnostic significance. The newly launched and used in our study anti-TPO and anti-Tg have very high significance for thyroid diagnosis. We found that anti-TPO antibody has primary information indicator and anti-Tg antibody is secondary information indicator for the diagnosis of thyroid disorder.Conclusion:1.Among 59 patients with thyroid diseases 89.8% (n=53) of them determined increased anti-TPO concentration and 61% (n=36) of them increased anti-Tg concentration. It shows increase of these antibodies have high diagnostic significance for thyroid diseases.2.For hyperthytiodism the anti-TPO has strong supportive information indicator (карра=0,64) and anti-Tg has primary information indicator (карра=0,84). 3.For hypothytiodism the anti-TPO has primary information indicator (карра=0,78) and anti-Tg has weak supportive information indicatot (карра=0,24).