Laboratory Quality Control PDF

\"Introduction\" What is quality? quality has many meaning: 1-A degree of excellence 2-conformance with requirements 3-The totality of characteristics of any entity that bear on its ability to satisfy stated or implied needs 4- fitness for use 5-Freedom from defects 6-delighting customers Q...

\"Introduction\" What is quality? quality has many meaning: 1-A degree of excellence 2-conformance with requirements 3-The totality of characteristics of any entity that bear on its ability to satisfy stated or implied needs 4- fitness for use 5-Freedom from defects 6-delighting customers QUALITY ASSURANCE Quality Assurance (QA): the practice which encompasses all activities, procedures, formats of activities directed towards ensuring that a specified quality or product is achieved or maintained. QA involves in every step in the analysis process from the initial ordering of a test and the collection of the patient sample (pre analytic), analysis of the sample (analytic), and finally the distriblation of result to the proper destination. QA program involves every person in the lab. From the director to the lab helpers, also includes everyone who has contributed to the enterprise such as the phlebotomy team and data processors. Quality Control (QC) Statistical QC is concerned with the analytical phase of quality assurance. It monitors the overall reliability of lab results in terms of accuracy and précision according to the criteria specified for each measurement. WHY IS QUALITY CONTROL NECESSARY? Proper validation and standardization of the assay. For every assay system there is an inherent level of error which must be accepted. A quality control program indicates when that level of error becomes unacceptable. Analytic error in quality control The total test process: The total testing process is the entire process from ordering of a test to the interpretation of test result. It starts and end with the patient, and can be subdivided into three phases. ➤ pre-analytical step ➤ Analytical step ➤ post-Analytical step Pre-analytical errors include: 1-Patient Identification 2-Patient Preparation 3\_Selecting the Site 4\_Site Preparation 5-Tourniquet Application 6-Order of Draw 7-Proper Tube Mixing 8\_Correct Specimen Volume 9-Transportation 10-centrifugation 11-storage Patient Identification: It is important to identify a patient properly so that blood is being collected from the correct person. Drawing blood from the wrong person or labeling the correct patient\'s sample with a different patient\'s label can certainly contribute to laboratory error. Blood should not be drawn from a patient before confirming that he is the right person. Patient Preparation: Prior to collecting specimens for chemistry, certain patient variables need to be considered. For certain chemistry analytes, such as glucose and cholesterol, patients need to be fasting (absence of food and liquids) for at least 12 hours prior to veni-puncture. Other analytes, such as cortisol and adrenocorticotropin, have diurnal variations, where the analyte is at its highest level in the morning, and the levels gradually decrease during the course of the day. Selecting the Site: Selecting the appropriate site for venipuncture can contribute to a better quality sample. The preferred site is the median cubital vein. This vein is usually the easiest to access. Generally, there is less need to probe to find the vein, which in turn should cause fewer traumas during the venipuncture. This will usually be the most comfortable for the patient. If the median cubital vein cannot be used, the next choice would be the cephalic vein.. The last vein to consider for venipuncture is the basilic vein. This vein is in close proximity to the median nerve and brachial artery, and extreme caution must be used so that only the basilic vein is being punctured. Site Preparation: Prior to venipuncture, the site should be cleansed with alcohol. Cleansing starts at the center of the vein, and should continue outward in concentric circles. Before performing the venipuncture, the alcohol should be allowed to air dry. This will help to ensure that the specimen is not contaminated with alcohol, as this can lead to hemolysis. Hemolysis can result in the spurious elevation of such analytes as potassium, lactate dehydrogenase (LD), iron and magnesium in the chemistry lab. Tourniquet Application and Time: The tourniquet should be applied approximately three to four inches above the venipuncture site. The tourniquet should be on the arm no longer than one minute. Prolonged tourniquet time can lead to an increase in various chemistry analytes, including serum protein, potassium and lactic acid due to heam concentration of blood at the puncture site. Order of Draw: According to BD and CLSI (Clinical and Laboratory Standards Institute, formerly NCCLS), following is the correct order of draw during venipuncture will help to ensure accurate test results. Improper order of draw that can lead to an incorrect chemistry result is drawing an EDTA tube prior to heparin tube for chemistry testing. The potential cross contamination of K2 or K3EDTA on the needle from the lavender top tube to the chemistry tube can lead to an elevated potassium result. This in turn can require a recollection of the sample, or possible misdiagnosis or treatment of the patient. Proper Tube Mixing: All tubes with additives need to be inverted to mix the additive evenly with the blood. Plastic serum tubes and BD SST tubes contain clot activator and should be inverted 5 times to mix the activator with the blood and help the specimen clot completely. Improper mixing of the tube after venipuncture could have contributed to the gelatinous serum sample. Other additive tubes, such as heparin, need to be inverted 8-10 times to mix the anticoagulant with the blood and prevent clotting. Be sure that tubes are not being shaken vigorously, as this can lead to a hemolyzed sample Correct Specimen Volume: All blood collection tubes need to be filled to the correct volume. This will ensure the proper amount of blood for the amount of additive in the tube (blood to additive ratio). For example, if a 5 mL draw heparin tube is only filled with 3 mL of blood, the heparin concentration is erroneously high and may potentially interfere with some chemistry analytes. 9-Transportation Use the correct type of container for your sample.Clearly label your sample with all the necessary information. Secure the lid or cap on the container. Pack samples in an insulated container with ice packs if necessary.suitable tempreture 10-Centrifugation: The next step in sample processing is the centrifugation of the blood collection tubes. In a swinging bucket centrifuge (preferred type of spin for gel separation tubes), the tubes should be spin for ten minutes at a speed of 1100 to 1300 relative centrifugal force (RCF). A fifteen-minute spin at the same speed is required for spinning tubes in a fixed angle centrifuge. Serum and plasma tubes without gel can be spin at a speed of 1000 RCF for ten minutes.It is important to spin gel tubes for the recommended time. The gel barrier in the tubes needs time to move and form a solid barrier between the red cells and the serum or plasma. Also, in BD PST tubes, the white blood cells and platelets that remain in the plasma need adequate time to spin out of the plasma. If the BD PST tubes are spin for less than the recommended 10 minutes, these cells and platelets may remain in the plasma and could cause interference with some chemistry analytes. 11-Requirements forStorage Refrigeration: Most blood samples require storage at 2- 8°C to preserve their integrity and prevent degradation. Frozen Storage: Certain samples, such as those for genetic testing, may need to be stored at -20°C or lower. ANALYTICAL ERRORS ➤Sample mix-up ➤Equipment failure ➤ Sample lose ➤ Incorrect sample dilution ➤ Test system not calibrated ➤ Improper measurement of specimens or reagent Incorrect reagent preparation ➤ Reagent stored inappropriately or used after expiration date ➤ Instrument maintenance not done ➤ Dilution and pipetting errors POST-ANALYTICAL ERRORS ➤ Reporting test results(wrong result reported) ➤ Incorrect Interpretation of test result ➤ Computer error(LIS) ➤Incorrect patient normal range ➤ Retesting if needed ➤ Calculation error Impact of analytical Errors on Patient Care 1:Misdiagnosis : analytical errors can lead to inaccurate test results, resulting in incorrect diagnoses and inappropriate treatment. 2 :Delayed Treatment Errors in sample collection or handling can cause delays in obtaining test results, impacting timely patient care. 3:Increased Costs analytical errors can lead to repeated tests, prolonged hospital stays, and additional medical expenses. 4:Patient Dissatisfaction Errors in the analytical phase can erode patient trust and confidence in the healthcare system. Strategies for Minimizing analytical Errors Staff Training: Provide comprehensive training on proper sample collection, handling, and processing techniques. Standardized Procedures: Develop and implement clear, standardized operating procedures for all analytical steps. Developing Quality Control program by: Identify potential sources of analytical errors and evaluate the associated risks.Monitor Performance.Continuous Improvement and Regularly review and update the quality control program to ensure its effectiveness Laboratory Quality Management System A Laboratory Quality Management System (LQMS) is a comprehensive framework of processes, procedures, and practices implemented within a laboratory to ensure overall quality. It involves systematic planning, control, and monitoring of all activities within the laboratory to comply with regulatory requirements, maintain reliable results, and enhance customer satisfaction. Laboratory processes that require quality practices include:  Sample handling and management  Equipment calibration and maintenance Method validation and verification  Quality control and quality assurance  Training and competency assessment  Document control and recordkeeping  Customer communication and satisfaction OVERVIEW about history of iso organization: ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September Summary of each section of iso 9001:2015 Requirements : Clause 1: Scope This section defines the scope of the 9001:2015 standard. In summary, the scope includes specifying requirements for a QMS of any organization clause 2: Normative References The supporting standard referenced in ISO 9001:2015 and is indispensable for its application is ISO 9000:2015 which covers terminology and fundamentals. This and other supporting standards make up the 9000 series. Clause 3: Terms and Definitions Terminology used throughout this standard comes directly from ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary. Clause 4: Context of the Organization When you are implementing your Quality Manual System (QMS), the first step for ISO 9001 requirements is to thoughtfully align your business objectives and intent with the QMS. Determine external and internal issues, the needs and expectations of interested parties, quality management system scope and its processes. Clause 5: Leadership The section on leadership outlines the requirements concerning top management, which are: promoting a customer focus all over the organization, developing and standing by a Quality Policy that sets direction and alignment, and determining responsibilities and authorities all over the QMS, to make clear who has the power to make decisions, and what is expected from every function working in the system. Clause 6: Planning for the QMS This section presents the requirements for determining and working with risks and opportunities, as well as those for setting quality objectives, aligned with the Quality Policy, and plans to meet them. Clause 7: Support Clause 7 is a very diverse section that includes requirements for management to provide resources, i.e., human resources, infrastructure (including equipment, hardware and software, and building facilities), work environment (including temperature control, humidity control, dust control, and sterilization control), the control of any equipment used to monitor or measure the product or service, and the organizational knowledge required to operate the QMS. The importance of competence, awareness, and communication for human resources is emphasized. Clause8: Operation Clause 8 covers the plan and control processes needed to meet the requirements for products and services (design and development, external providers, production and service provision, release of products and services, nonconforming outputs). Clause 9: Performance evaluation The performance evaluation section outlines requirements for assessing customer satisfaction, internal audit, monitoring, analysis, and evaluation of process performance. Also included are the requirements of the management review, including the mandatory inputs and outputs for the review. Clause10: Improvement ISO 9001:2015 requirements for clause 10 are based around continual improvement. Select opportunities for improvement, take action against nonconformities, implement corrective actions as necessary, and continually improve your quality management system Summary