DSEU Dwarka Campus B.Sc.-MLT (Sem-1) Topic – Documentations Why documentation ? • Medical diagnosis laboratories play a crucial role in deciding the course of treatment. Hundreds of laboratories test several thousand samples of blood, urine and other body fluids each day. A record of testing activities includes procedures adopted, calibration records of instruments, reference standards used, etc. The information will help you when you are in any trouble. Definition and types of Documents
Documents provide written information about policies,
processes, and procedures. Examples: Standard operating procedures (SOP) Records are the collected information produced by the laboratory in the process of performing and reporting a laboratory test. Examples: completed forms, charts, sample logs, patient records, quality control information, and patient reports. Policy
Policy is “a documented statement of overall intentions and
direction defined by those in the organization and endorsed by management “what to do” in a broad and general way. Processes Processes are the steps involved in carrying out quality policies(ISO:15189:2012) defines a process as a “set of interrelated or interacting activities that transform inputs into outputs.” (how it happens) Procedures Procedures are the specific activities of a process (ISO:15189:2012) . procedure is easily described as the performance of a test “how to do it” (SOP) Why are documents important? Documents are the communicators of the quality system. All policies, processes, and procedures must be written, so that everyone will know the proper procedures and can carry them out. Verbal instructions alone may not be heard, may be misunderstood, are quickly forgotten, and are difficult to follow. Examples : Quality Manual for ISO accreditation, Standard Operating Procedures (SOP),etc. Inventory Management Scientific method of finding out how much stock should be maintained in order to meet the production demands and be able to provide right type of material at right time, in right quantities and at competitive prices Inventory management techniques 1. Create a stock list a-Identifying low-turnover stock b-Demand forecasting c-Stock audit 2. Assign stock level a-Minimum stock level b-Maximum stock level 3-Organise your workspace 4- Create procedures for inventory management 5-Invest in lab inventory management software Laboratory Information Management System
LIMS started as a system to keep a record of test
samples, their results and all other particulars of donor and patients sample. It acts as an interface between the lab faculties and the database where all the information and essential details are stored. Importance of LIMS • Fewer transcription errors & faster processing with direct instrument uploads • Real time control of data quality with built in QC criteria • Direct report generation meeting specific client requirements • Direct electronic reporting to clients or direct client access to data