Laboratory Quality PDF

LABORATORY QUALITY Prof Dr AFAF DESOKY (2024) 1  Laboratory Quality Management What is Quality? ―Quality is defined as conformance to requirements, not as 'goodness' or 'elegance'.‖ Quality Indicators Definition Established measures used to determine...

LABORATORY QUALITY Prof Dr AFAF DESOKY (2024) 1  Laboratory Quality Management What is Quality? ―Quality is defined as conformance to requirements, not as 'goodness' or 'elegance'.‖ Quality Indicators Definition Established measures used to determine how well an organization meets needs and operational and performance expectations. Eight Steps to Developing Successful Indicators 1. objective 2. methodology 3. limits 4. interpretation 5. limitations 6. presentation 7. action plan 8. exit plan Essentials for Implementation Commitment Planning Structure Leadership Participation and Engagement leads to Continual Improvement How do we achieve excellent performance in the laboratory? Laboratory tests are influenced by laboratory environment knowledgeable staff competent staff reagents and equipment quality control communications process management occurrence management record keeping 2 Laboratory errors cost in time personnel effort patient outcomes The entire process of managing a sample must be considered: between. Twelve Quality System Essentials set of coordinated activities that function as building blocks for quality management Organization Personnel Equipment Organization 11— g1Personnel human resources job qualifications job descriptions orientation training competency assessment professional development continuing education Equipment acquisition installation validation maintenance calibration trouble shooting service and repair records Purchasing and Inventory 3  vendor qualifications supplies and reagents critical services contract review inventory management Process Control quality control sample management method validation method verification Information Management confidentiality requisitions logs and records reports computerized laboratory information systems Documents creation revisions and review control and distribution Records Collection review storage retention Occurrence Management complaints mistakes and problems documentation root cause analysis immediate actions corrective actions preventive actions 4 Laboratory Assessment External Proficiency testing (EQA) Inspections Accreditations Process Improvement opportunities for improvement (OFIs) stakeholder feedback problem resolution risk assessment preventive actions corrective actions Customer Service customer group identification customer needs customer feedback Facilities and Safety safe working environment transport management security containment waste management laboratory safety ergonomics A Brief History of Quality Management Innovator Date Cycle Walter A.Shewhart 1920s Statistical Process Control W. Edwards Deming 1940s Continual Improvement Joseph M. Juran 1950s Quality Toolbox Philip B. Crosby 1970s Quality by Requirement Robert W. Galvin 1980s Micro Scale Error Reduction In summary Quality management is not new. 5  Quality management grew from the good works of innovators who defined quality over a span of 80 years. Quality management is as applicable for the medical laboratory as it is for manufacturing and industry Facilities and Safety Secondary effects of a laboratory accident loss of staff confidence loss of reputation loss of customers increased costs litigation, insurance Negligence of laboratory safety is costly! N.B All diagnostic and health care laboratoriesmust be designed and organized forBiosafety level 2 or above Laboratory design Path followed by the sample reception and registration of patients sampling rooms dispatch between different laboratories analysis of samples Report delivery, filing Service rooms Safety during Service no unauthorized persons no friends no children no animals PleaseCLOSE the DOOR Sample collection room Stock room Doors and large equipment 6 Waste Premises high ceiling with good ventilation walls and ceiling use washable, glossy paint easy to clean and disinfect floor easy to clean and disinfect Benchtops non-porous covering, easy to clean,resistant to chemicals and disinfectants no wood, no steel Scheduled Cleaning daily bench tops floors weekly ceiling and walls other refrigerators freezers storage areas record date and cleaning staff Laboratory Hazards physical chemical biological Physical Hazards Needles, Broken Glass, and Sharps do not recap needles always use puncture-resistant, leak proof, sharps containers always use specific waste disposal containers never directly handle broken glass Chemical Hazards Biosafety Level 1 and 2 laboratories Separate cabinets for storage: 7  spill containment cabinet hazardous waste storage flammable liquids storage Biological Hazards Aerosols and droplets are the main sources of contamination Contamination Routes Ocular invasion Inhalation Ingestion Skin penetration Personal Protective Equipment laboratory coat gloves goggles or face shield masks hearing protection Chemical Spills anything beyond a minor spill and requiring help from outside of the laboratory group constitutes a major spill Biological Spills Facilities and Safety – Learn how to operate a portable fire extinguisher Laboratory Fire Safety Summary When designing a laboratory or organizing workflow, ensure that patients and patient samples do not have common pathways Summary Safety is dependent on: 8  a responsible supervisor a safety manual and SOPs trained personnel assessment of risks laboratory design Key Message Neglecting laboratory safety is costly. It jeopardizes the lives and health of employees and patients, and jeopardizes laboratory reputation, equipment, and facilities Selecting and Acquiring Equipment performance characteristics cost reagents Selecting and Acquiring Equipment easy to use safety will it fit? warranty language Negotiating Equipment Acquisition wiring diagrams software information parts list operator manual installation by manufacturer trial period Equipment Calibration perform initialcalibration use calibrators orstandards 9  follow manufacturer’sinstructions determine frequency of routine calibrations Function Checks Monitor instrument parameters: periodically, daily, weekly, monthly after major instrument repairExamples: incubator temperatures wavelength calibration autoclave temperature chart Create an Equipment Inventory Log Record: instrument type, model number,serial number location in laboratory date purchased manufacturer andvendor contact information warranty, note expiration date spare parts Troubleshooting: What is the source of the problem? Sample? Reagent? Water,Electricity? Equipment N.B Do NOT use equipment that does not function properly Service and Repair manufacturers laboratory must schedule routine manufacturer’s maintenance warranty may require repair handled by manufacturer in-house biomedical service technicians Documents 10 Develop written procedures for: routine maintenance function checks calibration troubleshooting manufacturer’s Service Dedicated Log Book Routine maintenance: calibration service repair by manufacturer all problems Function checks Recording Problems date problem occurred, equipment removed from service reason for breakdown or failure corrective actions taken date returned to use change in maintenance or in function checks Summary An equipment management program will address: equipment selection preventive maintenance procedures for troubleshooting and repair Documents and records will include: inventory of all laboratory equipment Information provided by the manufacturer on operation, maintenance, and troubleshooting records of all preventive maintenance and repair activities Equipment - Microbiology Monitor temperatures of: incubators refrigerators freezers Perform function checks for: pipettes autoclaves 11  pH meter weights and measures Maintain records Analyze Needs Conduct analysis of supply and reagent needs by: listing all tests in laboratory identifying all supplies needed for each test using available information to estimate usage Shelf Organization avoids ―losing‖ a product saves time systemizes storage space Number cold room or refrigerators and freezers and label shelves Definition Quality Control (QC) is part of quality management focused on fulfilling quality requirements QC is examining ―control‖ materials of known substances along with patient samples to monitor the accuracy and precision of the complete examination (analytic) process. Purpose The goal of QC is to detect errors and correct them before patients’ results are reported Quantitative Examinations Measure the quantity of a particular substance in a sample Measurements should be both accurate and precise Qualitative Examination Methods Examinations that do not have numerical results: 12  growth or no growth positive or negative reactive or non-reactive color change QC Summary important part of quality managementsystem goal is to identify errors and eliminate them before reporting patientresults different methods applied for quantitative, qualitative , and semi-quantitative results Definitions Accuracy The closeness of measurements to the true value Precisio The amount of variation in the measurements Bias The difference between the expectation of a test result and an accepted reference value Quality Control: Diagnostics Quality Control: Molecular Diagnostics Overview Sample Collection, Transport, and Processing maintain Nucleic acid integrity through these processes Contamination Control establish a unidirectional work flow from a DNA-free area for reagent preparation, to a sample processing area, to area where amplification and detection occur Positive and Negative Controls Reference: CLSI MM3-A (Molecular Diagnostic Methods for Infectious Diseases Continuous monitoring is the key element to success in the Quality System Summary Assessment is important in monitoring the effectiveness of the laboratory quality management system. Both external and internal audits yield useful information. An outcome of assessment is finding root causes of problems and taking corrective actions 13 Laboratory Staff laboratory’s greatest asset critical to quality partners in public health qualified professionals Summary Personnel management is critical to success of a quality management system. Job descriptions should accurately describe tasks and authorities. Competency must be assessed. Training will help to assure competentstaff. Methods for attracting and retaining personnel must be addressed Actions to meet patient requirements provide collection information provide collection facilities trained and knowledgeable personnel confidentiality of records maintenance of records Provide information for patients laboratory address and location –directions hours of operation bilingual/ multilingual staff Collection Requirements patient identification patient preparation type of sample required type of container needed labeling special handling safety precautions Good customer service provides: valuable information for best patient care valuable information to improvesurveillance professional image of laboratory 14 Summary Customer service is an integral part of a quality management system. It is important for the laboratory to: have commitment to process conduct planning and monitoring know and understand clients and theirneeds provide resources for program Meeting customer needs is a primary goal of the laboratory An active quality management system ensures laboratories meet all clientrequirements Everyone in the laboratory is responsible for quality, and therefore for customer service Good Documents are: clear concise user-friendly explicit accurate up-to-date Oveveiw Laboratory quality control (QC) and assurance are critical, particularly in highly regulated industries such as food, cosmetics, and pharmaceuticals. There are many definitions of quality, but in a laboratory setting, it generally refers to the accuracy and reliability of results. While inaccuracy is accepted to an extent, a strong quality management system will keep that level to a minimum. Quality and compliance go hand in hand and can form the backbone of an organization's viability. Lack of QC and assessment can lead to dire consequences for organizations and their customers. Lab staff strive to meet quality and compliance standards to ensure outputs are reliable and conform to regulations. Quality improvement in clinical laboratories is crucial to ensure accurate and reliable test results. With increasing awareness of the potential adverse effects of errors in laboratory practice on patient outcomes, the need 15 for continual improvement of laboratory services cannot be overemphasized. The robustness of the healthcare system relies upon the clinical laboratory because all the clinical decisions taken on patients by physicians mainly depend upon the clinical lab reports. About 70–75% of medical diagnoses are obtained via clinical laboratory reports, making laboratory service quality directly impact healthcare quality. Laboratory findings should be precise as possible, also at the same instance; all laboratory operations must be reliable with timely reporting resulting in a beneficial clinical setting. Negligence during laboratory operations, including processing, assessing, and reporting, can cause severe consequences, including complications, lack of adequate treatment, and delay in correct and timely diagnosis, leading to unnecessary treatment and diagnostic testing. A clinical laboratory is a complex set of cultures that include several activity steps, and many people make it unique and saucerful. The comprehensive set of these complex operations occurring during a testing process is called the path of the workflow. The workflow path in a clinical laboratory initializes with the patient and finishes with reporting and comprehending the results. In any clinical lab setting, it is presumed that mistakes will be made in this process due to the high volume of samples, the limited number of staff, and the different steps implicated in the testing process. Errors at any stage of the total testing process (TTP) can result in inaccurate laboratory outcomes. To guarantee the quality of the results, a reliable method for determining errors within the TTP is required. Laboratories are one of the most important places to provide services to patients within the health institution, which must be ensure the patient safety and care quality. Laboratory quality (LQ) is often outlined as precision, responsibility and time achieving of reportable check outcomes. lab outcomes should be correct, all aspects of lab. operations should be trusted, and time saving coverage for helpful during a clinical or public health setting. If unreliable outcomes submitted, the implications are often terribly vital, including: Unnecessary treatment or generally operations Treatment complications Medications side effects Missing necessary diagnoses Failure to produce the right treatment Increased price of aid. These consequences end in inflated cost, time and employees’ endeavors, and sometimes in poor patient outcomes. Minimizing lab mistakes to realize the very best level of precision 16 and responsibility, it's necessary for whole processes and procedures within lab. To be done at absolute excellent approach. The lab. is a complicated system, including several steps of activity and plenty of folks. The (QS) needs a lot of processes to be done. So, Quality System Management (QSM) model, that appear at the whole system, is extremely necessary to achieve smart lab. functioning. Laboratory quality control is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory. Quality control (QC) is a measure of precision, or how well the measurement system reproduces the same result over time and under varying operating conditions. Laboratory quality control material is usually run at the beginning of each shift, after an instrument is serviced, when reagent lots are changed, after equipment calibration, and whenever patient results seem inappropriate. Quality control material should approximate the same matrix as patient specimens, taking into account properties such as viscosity, turbidity, composition, and color. It should be simple to use, with minimal vial-to-vial variability, because variability could be misinterpreted as systematic error in the method or instrument. It should be stable for long periods of time, and available in large enough quantities for a single batch to last at least one year. Liquid controls are more convenient than lyophilized (freeze-dried) controls because they do not have to be reconstituted, minimizing pipetting error. Dried Tube Specimen (DTS) is slightly cumbersome as a QC material but it is very low-cost, stable over long periods and efficient, especially useful for resource-restricted settings 17 in under-developed and developing countries. DTS can be manufactured in- house by a laboratory or Blood Bank for its use. [5,6] Quality Control (QC) The principles of quality assurance, quality control, and quality management are bases for good laboratory results and workings. Every test in the laboratory gives a result. To be sure about the accuracy of the result is not possible until it is verified by some means. It is the quality control that will give confidence about the result. This is the duty of the technicians to be sure about the accuracy of the test result. Analytical sensitivity It is defined as the smallest amount of substance in a sample that can accurately be measured by an assay (synonymously to detection limit). Analytical specificity It is defined as the ability of an assay to measure one particular organism or substance, rather than others. Quality assurance: It consists of plans, policies, and procedures that provide an administrative structure for a laboratory’s efforts to achieve quality goals.  It has three components: 1. Assessment and monitoring. 2. Development of the program. 3. Quality improvement (quality control).  Quality assurance is vital to the patients, and this will need: 1. Quality can be assessed and monitored. 2. Quality program development. 3. Quality control improvement. 18   Quality control is one of the components of quality assurance. Quality assurance will check the entire testing process and will check quality regularly.  Quality can be assessed, monitored, and it can be improved.  Quality control will ensure the accuracy and reproducibility of the lab’s various tests.  QC checks the particular source of errors, estimates the magnitude of the errors, and alerts the laboratory personnel that quality has deteriorated.  Quality control results will be acceptable when these are in the acceptable range of the error limits.  Quality control (QC) results are unacceptable when these results show excessive errors and are out of the range. Ideal properties of QC materials are:  QC material should resemble human serum, plasma, blood, urine, and cerebrospinal fluid.  QC material should be stable for prolonged periods without any interfering preservatives.  QC material should be free of communicable diseases like bacteria, viruses, and fungi.  QC material should have a known concentration of the analytes. 19   QC material should be easy to store and dispense.  QC material needs to be affordable and not too costly. Quality control objectives are:  QC provides continuous accuracy of the results.  QC gives an early warning about the accuracy of the test so that early remedies may be taken to avoid great mistakes.  QC compares the tests at a different time from the same control sera. Many tools are used for quality control like:  Procedure manuals.  Maintenance schedules.  Calibrations.  Quality assurance program.  Training. Quality control will be different for the different disciplines of pathology:  Quality assurance for the blood transfusion.  Quality assurance for microbiology.  Quality assurance for biochemistry.  Quality assurance for surgical pathology.  Quality control for hematology. Quality control depends on:  The time between the collection and the performance of the test ex. Leukocytes and RBCs utilize glucose and cause a steady decrease in glucose concentration.  Specimen storage also causes an error in the result.  Evaporation of the sample may cause the wrong result, like electrolytes.  Exposure to light affects the Bilirubin level.  Refrigeration will affect lactate dehydrogenase (LDH).  The clerical mistake may occur at any stage. 20 Quality control purposes:  To maintain a continuous record of the precision of the tests.  It gives an early warning of the control trends, and early action will be taken before a great mistake occurs.  It provides valid judgment on the accuracy of results by comparison with the known sera.  This is very important for automated analyzers to check their performance.  Monitor the analytic process and help to find which method is more accurate.  This also helps to evaluate the technologist’s skills.  Determine analytical errors during analysis.  Prevent incorrect patient values.  The monitoring of the analytic values is compared with known standards and compared with their expected values. Quality control of various terms used are:  Accuracy means the true value of the analyte. This isn’t easy to define the true value of a substance. The value, in comparison to the known control, has some advantages.  Precision is the measure of reproducibility for that particular test. A method may give excellent precision but poor accuracy.  Mean is a basic statistical work, where this is the mean of the sum of data divided by the number of items.  The mode is the value that occurs most frequently in a list of data items. It is not affected by extreme values.  Standard deviation is a mathematical concept. This is very important because they are not acceptable if the mean values are outside of a standard deviation of >2.  Median when the data is arranged in ascending or descending manner, the number that occupies the central position is median.  Centile is the percentile; the value is greater than a specified percentage of the list of values. Analytic factors can be minimized, which depends upon instrumentation and reagents. 21   A schedule of daily and monthly preventive maintenance is needed for each instrument.  Keep a check on water quality, power supply, calibration of electrical balance, and calibration of glassware and pipettes.  Reagents and kits should be dated when received and when opened.  Run new lots of the reagents with the old lot in parallel before being used for analysis.  The primary standard is the most highly purified substance.  The secondary standard is one whose concentration is determined by analysis and compared with the primary standard.  Post-analytic errors are due to the recording and reporting of the results. Quality control material should be:  Available in sufficient quantity.  It should be stable for a period of a minimum of one year.  Keep in small volumes.  Its concentration should vary minimally.  Their composition should not vary from vial to vial.  Control material should be tested like the test sample. External quality assessment: This is the program in which the specimens are subjected to other laboratories for analysis, and the individual laboratory results are compared. This comparison can be made to the performance of a peer group of laboratories or to the performance of a reference laboratory. The term External quality assessment is sometimes used interchangeably with proficiency testing; however, External quality assessment can also be carried out using other processes. External quality assessment is here defined as a system for objectively checking the laboratory’s performance using an external agency or facility. Total quality management focuses on the following: 22   Customer. The users are doctors and nurses, while the customers are patients.  Management commitment.  Training of the workers.  Measurement through quality-improved tools.  Quality improvement occurs when the problems are permanently eliminated. Issues arise from imperfect procedures, of which 85 %. The remaining 15% of cases need action and performance improvements of individual employees. So the main problems are management problems, and management has the power to change the work process. Control of the preanalytical mistakes:  Patient identification and labeling are critical. Barcode technology has reduced these mistakes, which are common in handwritten labels.  Keep a record of the sample received and when the report is ready.  Check the request form, the test tube name, and the requested tests.  Check the adequate amount of the sample.  Observe if there is hemolysis or lipemic serum.  Take the history of food intake, alcohol, drugs, smoking, stress, sleep, and posture because these factors may influence the result.  Explain all instructions to the patient for the collection of the sample.  Incorrect containers and incorrect preservatives will affect the result.  Transport of the sample is very important and may be critical to some of the tests.  Processing the sample as a separation of the serum, where centrifuge speed, temperature, and the person are important. Analytic errors in quality control: Quality control errors in the laboratory are classified into: I. Random errors affect precision and are the basis for varying differences between repeated measurements. 1. These mistakes will increase the standard deviation. 23  2. These are present in pipettes and volumetric glassware with manufacturing defects. 3. There may be a defect in the instruments and spectrophotometer. 4. There may be a defect in the cuvet temperature. 5. There may be an effect of light, temperature, and evaporation on the serum or the plasma. 6. There may be interference from other substances in the analyzed sample. 7. Clerical errors are unavoidable and should not be accepted. a) Labeling the wrong name of the patients. b) Delay in the transport of the sample. c) Incorrect calculations. 8. These can be avoided by: a) Well-trained staff. b) By good working organization. c) Well-designed worksheets. d) Thorough checking of the results. II. Systemic errors indicate a constant difference, either increased or decreased. This may be caused by: 1. These errors will displace the mean value in one direction, which may go up and down. 2. There may be instability of the reagents. 3. There may be an inaccuracy in the standards. 4. If the method is nonspecific for the analysis. 5. Analysis of analytes by the kinetic method at 340 nm is critical. III. Some errors encounter both systemic and random errors. 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 24   Method validation and verification  Quality control and quality assurance  Training and competency assessment  Document control and recordkeeping  Customer communication and satisfaction It is important to distinguish between the Quality Management System (QMS) in the medical laboratory and an Electronic Quality Management System (eQMS). The laboratory QMS primarily concentrates on overseeing and ensuring quality within the laboratory’s operations. It encompasses processes, procedures, and protocols designed to maintain uniform and high quality and accuracy in testing, analysis, and reporting. On the other hand, an eQMS offers a digital solution for effectively implementing and managing QMS principles and processes in an electronic format. It serves as a specialized software designed to align with regulatory requirements and streamline the implementation of QMS principles. 25  In a medical laboratory, an eQMS supports the laboratory quality management system processes such as document management, change control, CAPA management, employee training, and more. Simpler QMS provides a comprehensive eQMS solution that encompasses all of the features and modules designed to streamline the efficiency of laboratory operations. These modules integrate seamlessly with the overall QMS framework, improving operational efficiency and supporting compliance with regulatory requirements. (1) Applicable Laboratory QMS Requirements models: Various applicable standards and regulations govern laboratory quality management. These ensure that laboratories adhere to specific requirements and maintain a high and uniform level of quality in their processes.  ISO 9001:2015 The ISO 9001:2015 standard is a general requirement for a quality management system. Although not tailored specifically for medical and clinical laboratories, ISO 9001:2015 requirements can still be followed by these laboratories to consistently deliver products and services that meet customers’ expectations and comply with regulatory requirements. 26   ISO/IEC 17025:2017 The ISO 17025:2017 standard establishes the requirements for testing and calibration laboratories to demonstrate their competency in testing and equipment calibration. Compliance with this standard indicates that a laboratory possesses the necessary knowledge, skills, and resources to produce reliable and valid results. It ensures that testing and calibration activities are conducted with impartiality, competence, and consistent operational practices. This way, laboratories can enhance their credibility, inspire confidence in their clients, and demonstrate their commitment to quality and accuracy. 27   ISO 15189:2022 The ISO 15189:2012 provides laboratories with a framework to develop robust lab quality management systems and assess their own competence. This standard aims to promote the welfare of patients and the satisfaction of laboratory users through confidence in the quality and competence of medical laboratories. ISO 15189:2012 covers a wide range of requirements, including but not limited to:  Quality Manual  Personnel training  Equipment calibration  Nonconformances  Complaints  Data retrieval and storage  Environmental conditions 28   Examination processes  Risk management  Control of records  Management reviews  ISO/IEC 17043:2010 The ISO 17043:2010 standard focuses on proficiency testing and sets forth the requirements for laboratories to participate in interlaboratory comparisons. Laboratories can test identical or similar samples under predetermined conditions, allowing them to evaluate their performance, identify areas for improvement, and demonstrate their competence in delivering accurate and reliable results. 29   CLSI HS01-A2 The Clinical and Laboratory Standards Institute (CLSI) HS01- A2 guideline specifies the requirements for a QMS model for healthcare organizations. It offers essential background information and infrastructure to establish a quality management system aligned with healthcare quality objectives. Implementing this guideline, along with other relevant CLSI documents, allows Life Science companies to apply the model to their unique processes.  CLSI GP26-A3 The CLSI GP26-A3 guideline outlines the requirements for applying a QMS model for laboratory services. It is a useful resource for improving clinical laboratory processes, workflow, and operations, meeting government and accreditation requirements. Combined with the CLSI HS01-A2, it provides a comprehensive framework for laboratories to implement a complete quality management system. 30   FDA 21 CFR Part 58 The 21 CFR Part 58 establishes Good Laboratory Practices (GLP) for nonclinical laboratories involved in research related to food and color additives, animal food additives, human and animal drugs, human medical devices, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the products and substances’ safety data.  Clinical Laboratory Improvement Amendments (CLIA) The CLIA refers to a series of adjustments made to the Public Health Services Act by the US Congress over time. These amendments have been implemented to safeguard the accuracy and reliability of testing conducted in laboratories that perform testing on humans.  FDA 42 CFR Part 493 The 42 CFR Part 493 is designed to ensure that medical and clinical laboratories that perform testing on humans operate safely and efficiently and produce accurate and reliable results. It requires laboratories to have a comprehensive quality management system that includes policies and procedures for all aspects of laboratory operations. Among the requirements outlined in this part of the regulation are:  Sample control procedures  Complaint investigations  Quality control and quality assurance  Proficiency testing  Personnel competency  Equipment calibration  Corrective and preventive actions  Test reporting 31 12 Elements of Laboratory Quality Management System (QMS) The 12 elements of a laboratory quality management system are the building blocks for a QMS framework in medical and clinical laboratories. Developed by the Clinical and Laboratory Standards Institute (CLSI), these quality elements are integral to laboratory QMS effectiveness. Neglecting any of these elements can compromise the success of the LQMS. Possibly leading to potential failures in achieving accurate and reliable laboratory results, maintaining regulatory compliance, and meeting customer expectations. The quality system essentials are illustrated in the diagram below. The following are the 12 essential elements of a laboratory quality management system, along with examples of how an eQMS, like SimplerQMS, streamlines these processes. Organization The organization refers to the laboratory’s management and the supporting organizational structure that facilitates the implementation of quality management practices. Management must actively support the laboratory QMS and emphasize its significance to the personnel. The management must also 32 ensure the laboratory possesses legal approval from regulatory authorities for its design and operations. The key organizational requirements for a successful quality system are listed below:  Leadership: Lab leaders must demonstrate commitment, vision, team- building skills, effective communication, and responsible resource management.  Organizational structure: The organizational structure should be well-defined, with a clear organizational chart and assigned responsibilities.  Planning process: Lab managers should have skills for effective planning, including defining timeframes, allocating responsibilities, managing resources, and financial planning. 33   Implementation: Management personnel should address project management, resource allocation, adherence to timelines, and goal achievement.  Monitoring: There should be processes for monitoring the quality management system, ensuring compliance with benchmarks and standards, and continuous improvement is important. Personnel Personnel is the most valuable resource in the laboratory. Their integrity, understanding of the importance of their work, and active participation in continuous improvement are essential for successfully implementing the quality management system.  Management is responsible for defining suitable qualifications for personnel in every laboratory position. Additionally, they must ensure that personnel receive proper training to meet education, skills, knowledge, and experience requirements.  Employees must undergo a performance evaluation to assess their competency, including policy adherence, safety compliance, communication skills, punctuality, and behavior.  The laboratory should maintain confidential employee records related to their work. In contrast, non-essential records may be stored with centralized departments like Human Resources.  Simpler QMS provides robust training management capabilities. The system automates training activities and securely stores employee records while ensuring GDPR compliance.  It streamlines the entire training process, from creating training plans and learning rules to tracking training deadlines and completion status.  Automated notifications for new training materials simplify staying up to date. Upon completion, personalized quizzes can be used to evaluate the effectiveness of the training. Equipment Effective equipment management is essential to a laboratory QMS, ensuring the laboratory’s ability to conduct accurate, reliable, and timely testing. 34 By implementing proper equipment maintenance, calibration, and documentation protocols, laboratories can ensure the integrity of their testing processes and the optimal performance of their equipment. When it comes to equipment management, careful planning is essential. Several key elements should be considered in the equipment management process:  Selection and purchasing: Laboratories should establish criteria to select equipment according to the applicable requirements.  Installation: Requirements for installing new equipment should be followed, and specific personnel should handle the installation.  Calibration and performance evaluation: Laboratories should perform equipment calibration and validation in new and existing instruments.  Maintenance: Laboratories should implement maintenance plans following manufacturer guidance.  Troubleshooting: A clear procedure should be in place for troubleshooting equipment issues.  Service and repair: The laboratory should assess the costs involved in obtaining service and repair for its equipment. Furthermore, it should assess the availability of such facilities in its area.  Retiring and disposing of equipment: Laboratories should have procedures for replacing old equipment and ensuring proper disposal. A technical operator is responsible for overseeing equipment in the laboratory, ensuring proper troubleshooting and maintenance. The laboratory must maintain a logbook with essential details about equipment, including tests performed and personnel involved. Using Simpler QMS software, medical and clinical laboratories can streamline calibration and maintenance activities and ensure compliance with regulatory requirements. The software streamlines equipment management tasks, such as equipment registration and qualification, making it easier for laboratories to maintain accurate information on their equipment. 35  It keeps track of calibration data and automatically sends notifications and reminders before calibration becomes due. Furthermore, it allows assigning the responsibility of calibration and maintenance to appropriate personnel. Purchasing and Inventory Constant availability of reagents, supplies, and services is crucial for efficient and cost-effective laboratory operations. Any interruption in testing, even for a short period, can severely impact clinical care, prevention activities, and public health programs. Establishing policies and procedures for managing critical materials and services is essential for successful purchasing and inventory management. Some of the key components to address are:  Supplier qualifications  Purchase agreements  Receiving, testing, storing, and handling materials  Tracking materials to individual patients  Assessing and maintaining inventory  Controlling expiration periods  Dispatching supplies to satellite laboratories  And others A successful purchasing and inventory management system in a laboratory quality management system can be achieved through the following actions:  Assigning responsibility  Evaluating laboratory needs  Establishing minimum stock requirements  Implementing electronic forms and logs  Adopting a digital system for receiving, inspecting, and storing materials  Maintaining an inventory system across all storage areas 36  For example, licensed drug manufacturers and laboratories must justify their stock levels of restricted chemicals to local drug regulatory authorities. Maintaining logs and forms ensures compliance and prevents penalties from regulatory bodies. With Simpler QMS, laboratories can effectively manage their supplier selection process by evaluating and qualifying suppliers based on relevant performance criteria. It facilitates the maintenance of an approved supplier list (ASL) and offers templates for contracts, surveys, and supplier evaluations. Additionally, the software sends automatic notifications and reminders for upcoming supplier certificate renewals. Simpler QMS streamlines the entire supplier qualification process, allowing laboratories to categorize suppliers, perform qualification tasks, and conduct reviews seamlessly. Process Control The key factor that determines the success and performance of a laboratory is its ability to manage and control all of its processes effectively. Sample management is essential to process control within a quality management system in laboratories. Effective sample management is crucial for accurate and reliable testing, leading to confident laboratory diagnosis. Precise laboratory results are essential for making informed therapeutic decisions and ensuring optimal patient care and outcomes. The sample collected must be standardized and represent the actual condition. The sample must be stored in recommended storage conditions to prevent damage as soon as it is collected. Sample management policies must include the following:  Information on the sample collection  How to handle urgent requests  Sample collection, labeling, preservation, and transport procedures  Safety practices in case of accidents  Methods for evaluating, processing, and tracking samples  Storage, retention, and disposal procedures  Among others It is essential to manage sample documents effectively to avoid any mix- ups or discrepancies that could lead to incorrect testing outcomes. Important 37 information such as sample identification, collection data, time, and required tests should be documented accurately. To facilitate efficient sample management and document control, Simpler QMS has robust document management capabilities. These features help streamline quality processes, ensuring all necessary information is recorded and accessible. By using Simpler QMS, laboratories can improve their document management practices and reduce the risk of errors or misinterpretations during testing. Information Management Information management is a comprehensive system encompassing all the necessary processes for efficiently managing patient data, including incoming and outgoing information. Test results and data are the final product of laboratory operations. To ensure accessibility, accuracy, timeliness, security, confidentiality, and privacy of patient information, laboratories must establish an efficient information management system. When developing an information management system, it is important to consider the following key elements:  Unique identifiers for patients and samples: The same identifier should be used every time a patient utilizes the service. Similarly, a unique identifier should be generated for every sample collected.  Standardized test request forms: Consistent forms must be used to request specific tests, ensuring clarity and accuracy in the information provided.  Logs and worksheets: Detailed records should be maintained to track the flow of samples, test results, and any relevant observations or actions taken during the process.  Checking processes to ensure data recording and transmission accuracy: Procedures should be in place to verify the correctness of recorded data and its proper transmission within the information management system. 38   Protection against data loss: Measures such as regular backups and data recovery mechanisms must be implemented to safeguard data from loss.  Protection of patient confidentiality and privacy: Strict protocols should be followed to maintain the confidentiality and privacy of patient information per applicable regulations and ethical considerations.  Effective reporting systems: Systems must be established to generate comprehensive and meaningful reports based on the collected data, facilitating analysis, decision-making, and communication of results.  Effective and timely communication: Efficient communication channels should be established to ensure a timely exchange of information among relevant laboratory personnel and patients. Simpler QMS offers a form and template management capability that can help improve the efficiency of laboratory information management processes. With pre-defined forms for patient information, logs, and results, laboratories can streamline data collection. The system offers a search function to retrieve relevant documents by searching keywords in the document title and content, such as name or patient number. Documents and Records Document and record management is an essential component of the quality system, encompassing the utilization and maintenance. The primary objective of maintaining QMS documentation is to ensure immediate access to information whenever required. Documents need to be regularly updated, and an effective document control system ensures that the latest versions are accessible and in use. Some examples of documents and reports include:  Quality manuals  Standard operating procedures (SOP)  Work instructions 39   Reference materials  Sample logbook  Patient test reports  Incident reports  Instrument printouts An automated document control software solution helps ensure precise data collection by providing a streamlined and efficient process. Simpler QMS offers Life Science eQMS with robust document control capabilities, for clinical and medical laboratories, enabling them to maintain audit-ready documents while accurately managing large volumes of data. By utilizing the eQMS, laboratories can enhance data accuracy and reliability, improving decision-making and operational excellence. The system facilitates easy retrieval of documents and ensures proper archiving when documents are updated. Explore our article on laboratory document control to learn more about the importance of proper document management in ensuring accurate and reliable results. Occurrence Management Occurrence management is essential for maintaining quality laboratory service by effectively addressing and learning from errors. It is integral to continual improvement, focusing on identifying and managing errors or near misses. An occurrence management program aims to correct errors in testing or communication that result from an issue and prevent their reoccurrence by improving the processes involved. The laboratory should establish a proper system for timely investigation of all laboratory issues and errors and occurrence management, including the following:  Establish a systematic process to detect all problems using available tools.  Maintain a comprehensive log of problem events, documenting errors, investigation activities, and actions taken.  Investigate and analyze the cause of identified problems, utilizing available information. 40   Implement necessary corrective actions, including preventive measures, if the problem is identified before the error occurs.  Detect and monitor any reoccurrence of the initial problem, considering potential systemic issues.  Communicate relevant information to all stakeholders, including those affected by the error. Occurrence management, also called incident management, is essential to every laboratory as it affects the quality of laboratory testing and results. Simpler QMS automates the recording and tracking of nonconformances, ensuring efficient handling of identified issues. The system also automates the notifications and reminders, ensuring that the relevant personnel is promptly informed when nonconformance tasks are assigned. This promotes accountability and facilitates timely action on identified issues. Moreover, Simpler QMS allows you to seamlessly link nonconformances to Corrective and Preventive Action (CAPA) processes. This integration allows for the systematic resolution of issues and the implementation of preventive measures to avoid their recurrence in the future. The software allows for comprehensive monitoring of nonconformances by product, process, customer, equipment, or supplier. Customizable views provide flexibility in analyzing and tracking nonconformances, facilitating data-driven decision-making and continuous improvement efforts. Assessment Assessment evaluates the effectiveness of a laboratory’s quality management system through internal and external audits and performance evaluation in external quality assessment programs. There are two types of audits: internal and external. Internal audits are conducted by personnel within the laboratory itself. Individuals from one department assess the operations of another department. The main objective of these internal audits is to identify and address any potential weaknesses or areas of improvement. In contrast, external professionals and experts who specialize in their respective fields conduct external audits. These audits have many purposes, such as accreditation, certification, and licensing. 41  The involvement of external auditors ensures impartiality and brings an objective perspective to assess the laboratory’s compliance with standards and regulations. With Simpler QMS, laboratories can streamline the audit process, saving valuable time and effort in achieving successful audit outcomes. The software simplifies creating audit plans, scheduling audits, assigning dedicated Issue Handlers, and attaching relevant evidence to audit findings. It provides a closed-loop workflow by directly escalating audit findings to Corrective and Preventive Actions (CAPAs), ensuring that issues are promptly addressed and resolved. Process Improvement Process improvement is a vital component of a quality management system, as it establishes a structured program to drive continuous improvement in laboratory quality over time. The Plan-Do-Check-Act (PDCA) cycle is a valuable tool for achieving continuous improvement in any process within quality improvement efforts. The cycle consists of four key steps:  Plan: Identify problems and potential weaknesses and gather relevant information to develop an improvement plan.  Do: Implement the developed plan and put it into action.  Check: Monitor and assess the effectiveness of the actions taken, utilizing review and audit processes. Revise the plan if necessary.  Act: Take any required corrective actions based on the evaluation and recheck the results to ensure the effectiveness of the solution. This cycle is a continuous process, initiating further planning for ongoing improvements in the laboratory. The ISO 15189:2022 in section 4.12 specifies a comparable set of activities for achieving continuous improvement within the laboratory. These are outlined as follows:  Identify potential sources of system weaknesses or errors  Develop improvement plans  Implement the plan  Review the effectiveness of actions through focused review and audit 42   Adjust the action plan and modify the system based on review and audit results. Processes like internal and external audits, external quality assessments, and management reviews are used to identify opportunities for improvement and can serve as the basis for Corrective and Preventive Action (CAPA). CAPA offers a systematic approach to tracking corrective actions and their effectiveness. However, manually handling CAPA processes can lead to delays and incomplete actions. Implementing an automated CAPA system can significantly improve this process. SimplerQMS offers a comprehensive CAPA management software solution that simplifies and automates the corrective and preventive action process. Laboratories can streamline CAPA activities such as data collection, routing, notifications, approvals, and follow-up, ensuring efficient and effective management of quality issues. The software provides a centralized platform to track CAPAs, monitor progress, and generate insightful reports, helping laboratories drive continuous improvement and achieve regulatory compliance. Customer Service Customer satisfaction is a major aspect of a quality management system. The primary objective of a medical laboratory is to provide quality test results to its customers, making it essential to ensure their satisfaction. To achieve this, the laboratory should clearly understand its clients, including patients, physicians, public health agencies, and the community. Additionally, the laboratory should remain attentive to customers’ needs and requirements. The laboratory quality manager is accountable for measuring customer satisfaction through surveys, indicators, and audits. They are also responsible for taking proactive measures to prevent and correct any issues identified during the assessment process. Implementing customer feedback systems enables the collection of real-time data on customer satisfaction levels. Customer complaints are a common form of customer feedback. With SimplerQMS’s complaint management solution, laboratories can efficiently track, manage, analyze, and resolve complaints within a single system. 43 It offers the convenience of storing all related documents in a cloud-based platform, enabling seamless access from anywhere. The software automatically sends notifications to the appropriate personnel, ensuring prompt attention to customer feedback. It provides valuable insights into feedback data, enabling effective utilization for product improvement and increasing customer satisfaction. Facilities and Safety The laboratory workspace and facilities should be designed to accommodate the workload while ensuring the quality of work and the safety of laboratory personnel. Neglecting laboratory safety can result in significant costs and adverse consequences, such as:  Loss of reputation  Loss of customers  Low staff retention  Increased costs related to human resources. The laboratory manager is responsible for both safety and quality in the laboratory. This includes actively participating in lab design, assessing potential risks, and providing valuable feedback to ensure the development of a safe laboratory environment. Risk assessment is essential for the laboratory to manage and minimize risks to employees effectively. Developing clear safety procedures for handling accidents, injuries, and contamination is vital. SimplerQMS can help laboratories identify and assess potential risks associated with processes, equipment, personnel, and patient safety. SimplerQMS Risk Management module allows laboratories to develop risk mitigation plans by defining appropriate control measures, implementing preventive actions, and establishing contingency plans. The software enables documenting risk mitigation strategies and assigning responsibilities to ensure effective implementation. Role of Laboratory Quality Management Software The purpose of laboratory quality management software is to streamline and improve quality processes within laboratories. This specialized software is a comprehensive solution that allows companies to manage and streamline 44 laboratory operations, ensuring compliance with regulatory standards and industry best practices. The software supports the 12 essential elements of the quality management system in medical laboratories by providing a unified platform for efficiently managing documents, equipment, personnel, processes, testing activities, and other processes. While eQMS for laboratories offers significant advantages, it is important to consider that a manual and hybrid approach may still be suitable for some companies, especially those with limited resources or specific operational requirements. The decision to adopt QMS software should consider the laboratory’s specific needs, resources, and regulatory requirements. SimplerQMS is specifically designed for Life Sciences, including medical and clinical laboratories. It provides robust support for compliance with several Life Science requirements. With its interconnected QMS modules, SimplerQMS offers key functionalities that align with the 12 essential elements of a laboratory quality management system. These modules include document management, employee training, nonconformance management, CAPA management, audit management, risk management, and more. SimplerQMS is a fully validated solution, validated according to ISPE GAMP5 guidelines. This means that all software validation processes are handled by SimplerQMS, eliminating the need for customers to allocate additional resources, time, or costs for software validation. Additionally, SimplerQMS provides pre-configured workflows, templates, and ongoing support to facilitate a smooth implementation and utilization of the software. This helps laboratories manage their quality management system efficiently, achieve compliance, and drive continuous improvement. To better understand the benefits of implementing an eQMS solution, we suggest downloading our eQMS Business Case template. This valuable tool provides a structured approach for assessing the value of an eQMS tailored to your company’s needs, facilitating effective communication of your findings to management. Using a business case analysis, you can uncover potential ROI, cost savings, efficiency increase, and compliance improvements, including compliance with standards and regulations. 45 Interpretation of lab. quality Interpretation of quality control data involves both graphical and statistical methods. Quality control data is most easily visualized using a Levey–Jennings chart. The dates of analyses are plotted along the x-axis and control values are plotted along the y-axis. The pattern of plotted points provides a simple way to detect increased random error and shifts or trends in calibration. Statistical quality control statistics Statistical quality control, the use of statistical methods in the monitoring and maintaining of the quality of products and services. One method, referred to as acceptance sampling, can be used when a decision must be made to accept or reject a group of parts or items based on the quality found in a sample. A second method, referred to as statistical process control, uses graphical displays known as control charts to determine whether a process should be continued or should be adjusted to achieve the desired quality. Acceptance sampling Acceptance sampling refers to the application of specific sampling plans to a designated lot or sequence of lots. Acceptance sampling procedures can, however, be used in a program of acceptance control to achieve better quality at lower cost, improved control, and increased productivity. This involves the selection of sampling procedures to continually match operating conditions in terms of quality history and sampling results. In this way the plans and procedures of acceptance sampling can be used in an evolutionary manner to supplement each other in a continuing program of acceptance control for quality improvement with reduced inspection. Assume that a consumer receives a shipment of parts, called a lot, from a producer. A sample of parts will be taken and the number of defective items counted. If the number of defective items is low, the entire lot will be accepted. If the number of defective items is high, the entire lot will be rejected. Correct decisions correspond to accepting a good-quality lot and rejecting a poor-quality lot. Because sampling is being used, the probabilities of erroneous decisions need to be considered. The error of 46 rejecting a good-quality lot creates a problem for the producer; the probability of this error is called the producer’s risk. On the other hand, the error of accepting a poor-quality lot creates a problem for the purchaser or consumer; the probability of this error is called the consumer’s risk. The design of an acceptance sampling plan consists of determining a sample size n and an acceptance criterion c, where c is the maximum number of defective items that can be found in the sample and the lot still be accepted. 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