Quality Management in the Medical Laboratory Questions and Answers

Quality Management in the Medical Laboratory Questions and Answers What's the laboratory "path of workflow" The core business in transforming a test order into the results report Does the laboratory perform and control all processes involved in the path of workflow? No True or false? The laboratory path of workflow is true for any size, scope, or specialty laboratory in the world. True What are the 3 main steps to the lab workflow path? Pre analytic Analytic Postanalytic What steps are involved in the preanalytic phase of the workflow path? Get ordering--- sample collection--- sample transport--- sample receipt/processing What steps are involved in the analytic phase of the workflow path? Testing--- results review and follow-up---- interpretation What steps are involved in the post-analytic phase of the workflow path? Result reporting and archiving---sample management The method for bringing the quality philosophy into the laboratorys workflow is by understanding and developing the aspects of quality which include: QC QA Quality management system (QMS) What is QC? Quality control Part of quality management focused on fulfilling quality requirements What is Quality assurance? Part of quality management focused on providing confidence that quality requirements will be fulfilled What is quality management? Coordinates activities to direct and control an organization with regard to quality Quality control provides a high degree of confidence that testing and _______ results are accurate for the batch of samples being tested or examined _______. Examination At that time QC monitors what method? The analytic method How does quality assurance differ from QC? QC involves looking specifically at one test method to monitor it's efficacy. QA looks beyond just one test method and assessing how the entire laboratory work flow is functioning. It's a set of planned actions that provide confidence that processes other than the test methods that influence the laboratorys results no reports are working as expected. How does the quality management system differ from QC and QA? It represents a way to ORGANIZE all the policies, processed, and procedures* that any laboratory needs to meet all requirements for laboratory regulatory organizations True or false? QMS includes both QC and QA. True How are all the policies, processes, and procedures organized to meet the requirements of the regulatory and accreditation organizations standards? 12 quality systems essentials (QSE's) How does QM differ from compliance with requirements? Compliance simply means that deviations and deficiencies are corrected periodically whereas QM is an active process whereby quality is monitored continuously What are the 12 essentials of QMS? Oranigzation Customer focus Facilities and safety Personnel Purchasing and inventory Equipment Process management Documents and records Information management Nonconformance management Internal and external assessments Continual improvement