ABSTRACT
Background@#The past decade has seen an increasing involvement of private for-profit medical laboratories in the national healthcare provision. But the majority of patients still use services of public hospital laboratories. @*Goal@#The goal of the survey was to assess the status of private and public medical laboratories based on ISO 15189 requirements.@*Method@#The overall capacity of seven private and seven public laboratories was assessed using a questionnaire based on ten main requirements of ISO 15189.@*Results@#In general, the public laboratories scored better that the private laboratories but the difference was not significant (79 points for public laboratories vs. 72 points for private laboratories; p=0.115). The main differences were in the areas of equipment management (82 points for private vs. 92 points for public; p=0.025) and testing performances (77 points for private vs. 91 points for public; p=0.006). Out of the remaining eight assessment sections, the private laboratories scored better, but not significantly, in the areas of laboratory management and laboratory information system.
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.