LQM I 1st Lecture by د.دينا PDF

Quality: Is the degree of excellence of a product, service, or process when it fulfills or exceeds customer expectations Laboratory quality: defined as accuracy, reliability and timeliness of reported test results. The laboratory results must be as accurate as possible, all aspects of the laborato...

Quality: Is the degree of excellence of a product, service, or process when it fulfills or exceeds customer expectations Laboratory quality: defined as accuracy, reliability and timeliness of reported test results. The laboratory results must be as accurate as possible, all aspects of the laboratory operations must be reliable, and reporting must be timely in order to be useful in a clinical or public health setting Quality Management System in the medical laboratory requires quality in all steps. The test results must be accurate and reliable, and reports must be produced on time without tampering ⚫Quality means quality of delivering the products, is demonstrated work content, quality of service, quality of process, quality of systems, quality of delivery, quality of people; including workers , engineers, managers, and executives, and indeed the quality of entire organizations. ⚫Quality can be expressed as a ratio: Where: P=performance And Results E=expectations Of Consumers ⚫Degree to which the outputs (products and services) from the system conform to requirements or meet customer expectations. ⚫The focus is on quality attributes (e.g., conformance, performance, convenience, responsiveness, perceived quality.)  Consumer’s Perspective  Fitness for use  how well product or service does what it is supposed to  Quality of design  designing quality characteristics into a product or service  A Mercedes and a Ford are equally “fit for use,” but with different design dimensions LABORATORY FUNCTIONS THAT REQUIRE QUALITY PRACTICES INCLUDE: Environment Quality procedures Record keeping Expert human resource Quality reagents Quality equipment and instruments For example, a Sensor in a Stability Chamber records the humidity levels for a product. If the sensor becomes faulty, the laboratory is responsible for investigating the root cause. The laboratory is also responsible for taking preventive actions to prevent the recurrence of the problem.  Noting that the Quality Management System (QMS) in a laboratory environment is different from an Electronic Quality Management System (eQMS) or quality management software  In a medical laboratory environment, an Electronic Quality Management System (eQMS) can assist Laboratory Quality Management System (LQMS) functions such as Record Keeping, CAPA Management, Document Control  STANDARDS GOVERNING LABORATORY QUALITY MANAGEMENT SYSTEM (QMS)  The Laboratory QMS is an ISO standard adopted by its all member countries.  There are two applicable ISO standards – ISO 15189 and ISO 17025. ISO 15189 – Medical laboratories — Quality and Competence It is an international standard that specifies the requirements for quality and competence in medical laboratories. This standard guides the development of the laboratory’s quality management system, technical solutions, and administrative sections that are the main factor for a laboratory’s functioning. Any laboratory, regardless of test or assessment, can use this standard.  ISO 17025 – Testing and Calibration Laboratories ISO 17025 standard is developed for laboratories that perform calibration and testing. It enables the calibration performing laboratory to prove accuracy in results. This helps increase customer trust around the world, harmony among all laboratories, and eliminates the need for further testing. 12 ESSENTIALS OF LABORATORY QUALITY MANAGEMENT The framework of the Laboratory Quality Management System (LQMS) is divided into 12 quality system essentials. The Clinical and Laboratory Standards Institute (CLSI) develops these principles. These quality principles act as an individual building block for an effective laboratory QMS. If one of them is overlooked, LQMS cannot be successful and can fail eventually. 1- ORGANIZATION  The organization is defined as the management’s role and commitment in implementing Laboratory Quality Management System (LQMS).  The management must support the Laboratory QMS and establish ways to highlight its importance to the staff.  The laboratory’s design approval and functioning must have recognized legal status from a local regulatory body. 1.2. KEY ORGANIZATIONAL COMPONENTS DEFINED UNDER THIS QUALITY PRINCIPLE INCLUDE: Leadership – leader’s commitment to implementing LQMS by team building, motivational, and communication skills. Organizational structure – an organization’s structure must be clearly defined, indicated by an organizational chart. Planning process – management should plan for skill development. Implementation – management should address any issues in implementing LQMS. Monitoring – monitoring systems for ensuring LQMS design according to standards. Monitoring is also necessary for Continuous Improvement. For example, management must provide a Job Description (JD) to every staff. JD should indicate their role, responsibility, who are their subordinates, and to whom they report. Suppose there is any change in organizational structure, such as in the case of employee promotion. In that case, the concerned person should update the Job Description with information to all relevant organizational functions. 2- PERSONNEL Personnel are a critical quality principle they are the ones implementing and following Quality Management System (QMS) in a laboratory. The personnel must be responsible, knowledgeable, understand the importance of quality, and be willing to be a part of continuous improvement. The Laboratory Director is responsible for developing correct Job Descriptions and hiring appropriate staff. He is responsible for training, competency assessments, and annual employee performance appraisals. He is also responsible for staff’s continual education to update the personnel with the latest technologies and trends. All employees must go through a performance appraisal. This is an advanced stage of competency assessment and includes more detailed evaluation such as adherence to policies, observance of safety rules, communication skills, punctuality, and behavior The laboratory should keep employee records regarding their lab work, which becomes essential when calculating their benefits. The employee record must be in a safe place and remain confidential. Records, unimportant for laboratory function, may be kept with other centralized departments such as the Human Resource. For example, seminars or exhibitions provide an excellent way of keeping employees updated with the latest technologies. After the visit, the participants may submit a report about the visit consisting of knowledge gained, the relevancy of the visit, and suggestions for further improvement if necessary.  3- EQUIPMENT Proper functioning equipment can have many advantages, such as increased performance, increased confidence, and reliability in results. It also lowers repair costs and increases service life. The benefits of a good equipment management programme are many: helps to maintain a high level of laboratory performance; reduces variation in test results, and improves the technologist’s confidence in the accuracy of testing results; lowers repair costs, as fewer repairs will be needed for a well- maintained instrument lengthens instrument life; reduces interruption of services due to breakdowns and failures; increases safety for workers; produces greater customer satisfaction. 3.1. EFFICIENT EQUIPMENT MANAGEMENT CAN BE ACHIEVED BY THE FOLLOWING: Selection and purchasing – the purchased equipment must be according to laboratory requirements. Installation – equipment must be installed according to requirements. Equipment calibration – system for performing medical test equipment calibration processes must be in place. Maintenance and troubleshooting – preventive maintenance must be made part of maintenance. It requires developing maintenance plans and following the plan accordingly. Validation – the department should perform equipment validation before the equipment goes into operation.  A technologist in a laboratory can be responsible for all the equipment in a laboratory.  Commonly, a technical person competent in troubleshooting and maintenance is made accountable.  They oversee all the equipment activities and functions.  The laboratory must maintain a logbook regularly detailing all the vital information about equipment.  For instance, a logbook can include information such as the test performed, the person performing the test, and more. 4- PURCHASING AND INVENTORY Adequate inventory of components such as reagents is crucial for reliable and satisfactory laboratory performance. If there is an unavailability of any item, it can delay the testing process. Proper purchasing and inventory principles ensure sure that inventory is available when required, operations are efficient and cost-effective. 4.1. A RELIABLE PURCHASING AND INVENTORY MANAGEMENT MUST FULFILL THE FOLLOWING REQUIREMENTS: Supplier Qualification Purchase agreements All received materials must be inspected for accurate specifications. The received materials must be stored as per recommended requirements, to avoid waste or change in their specifications. Tracking the items to their final destination Maintaining Inventory Controlling expiration date Dispatching items 4.2. A SUCCESSFUL PURCHASING AND INVENTORY MANAGEMENT SYSTEM IN A LABORATORY Quality Management System (LQMS) can be successfully implemented by the following steps: Assigning responsibility Evaluating Laboratory Needs Developing Minimum stock requirements Developing and using electronic forms and logs Digital System for receiving, inspecting, and storing received materials For example, the use of certain chemicals is prohibited by the general public and is only allowed to be used by licensed drug manufacturers or laboratories. They must justify their stock levels against usage to the local drug regulatory authorities. For this purpose, logs and forms are highly important and help in averting penalties from the regulatory bodies. 5- PROCESS CONTROL The main driver of laboratory success and satisfactory performance is how well the laboratory can handle and control all processes. One of these processes, critical to laboratory performance is sample management. The sample collected must be standardized and represents the actual condition. As soon as the sample is collected, it must be stored with recommended storage conditions to prevent damage. Accurate sample management starts with good sample collection practices THIS PRACTICE MUST BE IN WRITTEN FORM AND INCLUDE THE FOLLOWING: Information required on the sample collection form How to handle urgent requests Sample collection, and Labelling Preservation and transport Safety practices such as in case of leaked or broken containers Evaluating, and Processing samples Storage Disposal They must be accurately labeled to avoid sample mix. The label should contain critical information such as Sample Identification, Collection data, time, tests required, etc. If not correctly labeled, the chances are that sample will undergo the wrong test, leading to erroneous results. 6- INFORMATION MANAGEMENT The information management principle focuses on the accuracy, security, confidentiality, and privacy of a patient. The final product of a laboratory is data, which often contains critical information about the patient that they do not want to disclose SOME ELEMENTS OF THE INFORMATION MANAGEMENT PRINCIPLE INCLUDE: Unique identifiers – for patients and samples, every time patient utilizes the service, the same identifier is used. Similarly, a unique identifier is generated for every sample collected. Standardized test request forms – for necessary information collection when requesting a test. Logs and worksheets – for recording sample data at the arrival of the laboratory. Checking processes – to assure the accuracy of data recording and transmission Data protection against loss Protection of patient confidentiality and privacy Effective reporting systems Effective and timely communication 7- DOCUMENTS AND RECORDS These quality principles focus on laboratory documents and records. The required information must be available when desired. They must be updated every time a policy, process, or procedure changes. Standardized forms and formats must be used for recording information. The quality manual is a document that describes the quality management system of an organization (ISO 15189). Its purpose is to: clearly communicate information serve as a framework for meeting quality system requirements convey managerial commitment to the quality system. Examples of documents include quality manuals, standard operating procedures, work instructions, and others. Specific documents common to work processes should be accessible to specific personnel based on their job role. With an automated document control software solution, you can collect data with precision. It enables the automatic generation of documents in approved formats with necessary approvals. It also ensures that only the current and updated version of documents is always available. Such software solutions provide access to documents from a single system and prevent manual record- keeping in all critical departments 8- OCCURRENCE MANAGEMENT Occurrence management focuses on continual improvement. An occurrence is an action or event that can harm the staff in a laboratory, performance, equipment, or environment. It identifies errors or near misses in testing or communication and devises necessary steps to prevent these errors from reoccurring. When occurrences are found, they must be investigated for the root cause. This prevents recurrence in the future. After occurrences are detected, they can be rectified by taking appropriate Corrective and Preventive Actions (CAPAs). Corrective action and preventive action (CAPA) comprises a set of actions aimed to improve an organization’s processes by eliminating the causes of recurring non-conformances and other unwanted situations. The laboratory should maintain a proper system for occurrence management, including the following: Establishing a process to detect problems Log of all problems, and respective investigative and remedial actions Investigating cause Necessary action Prevent recurrence by monitoring the original problem Knowledge sharing to all who need it and those affected For example, for a given sample, the result failed to pass the test. Although, before the trial, all pre-analytic indicators were satisfactory, so it was assumed that the results would also be satisfactory. The laboratory decided to crosscheck and gave the test to another person, which passed the sample test. The investigation revealed that the reagent used by the first person was expired, and he failed to identify the expiry date. To prevent the recurrence of this problem, the first person was trained for reagent identification, and performance was evaluated for satisfactory working. 9- ASSESSMENT Assessment is an integral quality principle that evaluates all the functions of a laboratory quality management system (LQMS) and demonstrates that it is meeting regulatory and customer requirements. International Organization for Standardization (ISO) uses the audit instead of assessment. THERE ARE TWO TYPES OF AUDIT – INTERNAL AND EXTERNAL The laboratory’s internal people perform internal audits. People working in one area perform an audit of another area. The primary purpose of conducting an internal audit is to identify any potential weaknesses. On the other hand, external audits are carried out by external professionals and experts in their relevant fields, and significant purposes include accreditation, certification, or licensure. For example, personnel involved in sample testing can perform an internal audit of the sample collection procedure. They can assess different stages of sample collection, such as label quality, transportation, and sample storage Audits should include the evaluation of steps in the whole laboratory path of workflow. They should be able to detect problems throughout the entire process  Simpler QMS can help you reduce the time and effort needed to pass audits successfully. It allows you to link a response or CAPA to the audit findings.  Digital audit management solution automates data collection, routing, notifications, and approvals and stores all data in centralized, cloud-based storage which allows you to conduct remote audits seamlessly.  The system also automates task assignments to individual persons and tracks their progress against their due date. 10- PROCESS IMPROVEMENT Process Improvement is continual improvement, requiring continual efforts in improving processes The Deming Plan-Do-Check-Act (PDCA) cycle shows how to achieve continual improvement in any process. According to ISO 15189, the continual improvement process should: Identify potential sources of any system weakness or error Develop plans to implement improvement Implement the plan Review the effectiveness of the action Adjust the action plan and modify the system following the review and audit results Some techniques useful for process improvement include internal and external audits, external quality assessment, and management review of all data gathered. The output of these tools is the opportunities for improvements (OFIs), providing the basis for the corrective action. Some new tools, Lean and Six Sigma, have also been included together with the traditional tools. 11- CUSTOMER SERVICE  Customer service is a crucial quality principle and forms the basis of developing a quality management system in a laboratory environment.  There can be many customers for the laboratory, including patients, physicians, public health agencies, and communities.  The laboratory head is responsible for ensuring and measuring the degree of customer satisfaction.  Different mediums can be used to measure satisfaction, such as surveys, indicators, and audits.  Customer feedback systems can be deployed for every customer. Such a solution would allow real-time data gathering about the satisfaction level Important information on customer satisfaction may be obtained using: complaint monitoring quality indicators internal audit management review satisfaction surveys interviews and focus groups. 12- FACILITIES AND SAFETY This quality principle focuses on the safety of laboratory staff and the quality of work. Lack of attention to this principle can lead to negative consequences such as: Loss of reputation Loss of customers Low staff retention Increased costs related to human resource Laboratory Safety and quality are the responsibility of the laboratory head. He/she must actively participate in lab designing, assess all potential risks, and provide feedback on developing a safe laboratory. To ensure safety and quality of work, there must be an adequate supply of safety equipment such as: Personal protective equipment (PPE) Fire extinguishers Appropriate storage for flammable and toxic chemicals Eye washers, and emergency showers Waste disposal supplies and equipment First aid equipment A waste management system must be responsible for the safe disposal of waste, particularly harmful contaminated waste. For example, a regular evacuation drill can be helpful in case of a real fire. It allows the laboratory head to evaluate the safety routes, the safety kit, and the lab staff also becomes informed of emergency practices. MCQ 1- Equipment management is one of the essential elements of a quality management system The benefits of a good equipment management programme are many: a) increase variation in test results, and improves the technologist’s confidence in the accuracy of testing results; b) high repair costs, as fewer repairs will be needed for a well- maintained instrument lengthens instrument life; c) reduces interruption of services due to breakdowns and failures; d) Decrease safety for workers 2- - is an essential element of the quality management system, and refers to control of the activities employed in the handling of samples and examination processes in order to ensure accurate and reliable testing. a) Quality assurance b) Quality Control c) Quality Management System d) Process control 3- defined as the systematic examination of some part (or sometimes all) of the quality management system to demonstrate to all concerned that the laboratory is meeting regulatory, accreditation and customer requirements. a) Quality Control b) Quality Management System c) Process control d) Assessment 4- ----------- Is the degree of excellence of a product, service, or process when it fulfills or exceeds customer expectations A) Policies B) Assessment C) Quality D) Process control 5- Laboratory functions that require quality practices include: a) Environment b) Quality procedures c) Record keeping d) All Above 6---------------- is defined as the management’s role and commitment in implementing Laboratory Quality Management System (LQMS). a) Assessment b) Quality c) Process control d) Organization 7- Which of the following is NOT a responsibility of a clinical laboratory director? a) Selecting test menus for the lab. b) Hiring personnel. c) Attending all Florida Board of Clinical Laboratory Personnel meetings. d) Ensuring that competency of testing personnel is periodically assessed. 8- The information management principle focuses on the accuracy, security, confidentiality, and privacy of a patient. a) True b) False 9- the safety of laboratory staff and the quality of work lead to negative consequences such as: Loss of reputation and Loss of customers a) True b) False 10- --------------------- is a document that describes the quality management system of an organization (ISO 15189). a) Quality Control b) Quality Management System c) Process control d) Quality manual