Clinical laboratories must adhere to Good Laboratory Practices (GLP) to ensure the quality, integrity, and reliability of patient results. GLP principles include organization and personnel, a quality assurance program, facilities, equipments, reagents and materials, test systems, standard operating procedures, result reporting, and archiving of records and reports (Wikipedia,2010). This chapter presents a review of the latest requirements in quality control and quality management in certified

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... inical laboratories. We will describe different stages in clinical testing procedures and highlight the critical steps that need to be monitored using quality assurance indicator tools. In addition, we will present our latest contribution to the field of quality control computer software which encompasses an innovative approach in monitoring quality control and quality assurance in laboratories. Accumulating and analyzing quality control data as well as quality indicators help in developing the performance improvement plan in the laboratory. Performance improvement is a process which uses information from multiple sources to increase the probability of accomplishing desired outcomes to better serve the needs and expectations of patients. The most frequently used performance improvement tools are: 1. FOCUS-PDCAframework for improvement, 2. Failure Modes and Effects Analysis (FMEA), 3. Root Cause Analysis (RCA) and 4. Control Charts. However, in this chapter we will focus on one model of quality improvement approaches which is FOCUS-PDCA and control charts and give examples on its implementation in a clinical laboratory setting. Imperative At the end of this chapter, you will be able to understand different stages of analytical testing; differentiate between internal and external controls, analyze common problems associated with invalid test results, have an overview of different QC software and our contribution to advance these programs. Traditionally, medical laboratories used conventional paper-based systems for assessing quality of medical tests performed in the laboratory. The main drawbacks for these traditional quality control monitoring systems can be summarized in the following points. Manual paper-based quality monitoring systems have a long lag time between tests and application of quality control procedures. The absence of a reporting system of the different www.intechopen.com Applications and Experiences of Quality Control 274 system variables hinders the long-term planning and expansion of the system. Clinical laboratories that are still using these traditional ways of monitoring the quality control results have reduced reliability and productivity as there have been manually applying and assessing quality control rules such as Westgard rules (Al-Taee,2009). Because of these problems and the desire to deliver high quality services, most of modern medical laboratories are planning to gradually transform all administrative and communicative work to become electronic. Hence, ample efforts are put in automating the quality control process in clinical laboratories in order to increase quality of the results. Several quality control programs are commercially available; however, we created a new program that captures the results entered by each medical technologist. The program analyzes the validity of each test, suggests corrective action(s) for failed quality control data as well as reports the number of failures in performing the daily quality control per each technologist. This not only confirms validity of the implemented quality control process, but delivers higher confidence in lab testing procedures, and allows for more reliable test results. Moreover, analyzing failure reports generated by the program which are related to poor performance enables the medical director in assessing the medical technologists' competency in addition to evaluating the performance of the instrument/ clinical analyzers. Furthermore, this data can be used in setting Quality Improvement plans in the laboratory (Al-Taee,2009). Quality management in clinical laboratories Stages in performing analytical tests All analytical tests are divided into three stages: Pre-analytical stage, analytical stage and a post analytical stage. Pre-analytical stage The pre-analytical stage is the stage that precedes the tests analysis. This stage consists of several factors such as: Written policies and procedures, requisition for analysis, preparation of patient, patient identification, effective blood collection, mixing with anticoagulants, storage until transportation, transportation collection or courier service (Sharma,2009), and keeping accurate laboratory logs to ensure complete records of specimen arrival. These steps are performed by physicians, nursing staff, doctor's assistant and laboratory staff. Recent statistics have shown that 46-68.2% of total laboratory result errors are due to pre-analytical factors (Plebani,2006). Hence, controlling these steps by monitoring them and analyzing the data reduces the infidelity in lab test results.