clinical laboratory quality assurance manual

Design and Development (Excluded). Customer Property (Excluded). Control of Measuring and Test Equipment. Preventive Maintenance. Estimate of Uncertainty of Measurement. Reference Standards and Standard Reference Materials. Data Validation. Measurement, Analysis, and Improvement of the Quality System. Statistical Methods. Subcontracting Services and Supplies. Quality Audits. Nonconformity. Customer Satisfaction and Complaints. Corrective and Preventive Action. Method Validation. Reliability. Quality Cost Reporting.Establishing Objectives and Priorities. Collection and Review of Existing Procedures. Preparation of a Flowchart. Identification of Program Requirements. Identification of Shortfalls and the Assignment of Priorities. Writing the Manual. PART 3: XYZ LABORATORY QUALITY ASSURANCE MANUAL. PART 4: SAMPLE QUALITY ASSURANCE FORMS. Index. It is an ongoing, comprehensive program which analyzes every aspect of an entire operation; it involves determining a quality goal, deciding whether or not the goal has been achieved, and implementing corrective action if the goal has not been reached. The Code of Federal Regulations (42 CFR 493) states laboratories “must establish and follow written policies and procedures for a comprehensive quality assurance program that is designed to monitor and evaluate the ongoing and overall quality of the total testing process.” As the saying goes, if it is not written down, it did not happen. The lab is to have systems in place to evaluate the effectiveness of corrective actions in regard to the QC program, including: The lab is to assess the effectiveness of corrective action taken to address any unacceptable, unsatisfactory, or unsuccessful PT results. If a laboratory has more than one method of performing the same test, the lab must (twice a year) evaluate and define the relationship between the two methods (i.e., run the same specimen by each method and check for comparable results).

• clinical laboratory quality assurance manual, clinical laboratory quality assurance manual.

To browse Academia.edu and the wider internet faster and more securely, please take a few seconds to upgrade your browser. You can download the paper by clicking the button above. The 13-digit and 10-digit formats both work. Please try again.Please try again.Please try again. Used: GoodVery minimal damage to the cover including scuff marks, but no holes or tears. The dust jacket for hard covers may not be included. Binding has minimal wear. The majority of pages are undamaged with minimal creasing or tearing, minimal pencil underlining of text, no highlighting of text, no writing in margins. No missing pages.Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. Please try again later. Murph's 4.0 out of 5 stars. Would you like to change to the United States site? To download and read them, users must install the VitalSource Bookshelf Software. E-books have DRM protection on them, which means only the person who purchases and downloads the e-book can access it. E-books are non-returnable and non-refundable.This is a dummy description.This is a dummy description.This is a dummy description.This is a dummy description.Introduction. Title Page. Letter of Promulgation. Quality Policies. Quality Objectives. Management of the Quality Manual. Control of Quality Documentation and Records. Customer Focus. Quality System Planning. Organization for Quality. Communications. Management Review. Human Resources. Laboratory Infrastructure. Work Environment. Quality in Procurement. Sample Handling, Identification, Storage, and Shipping. Chain-of-Custody Procedures. Laboratory Testing and Control: Intra-and Interlaboratory Proficiency Testing.

QC refers to those measures that must be included in each assay to verify that the test is working properly. QA is defined as the overall program that ensures that the final results reported by the laboratory are as correct and accurate as possible. Inaccurate meningitis diagnostic results can have significant consequences at the patient care or public health level. At the patient care level, errors can lead to: A quality management system, which oversees the entire system, is very important for achieving optimal laboratory performance. Laboratory processes can be grouped into pre-examination, examination, and post-examination categories. Quality management measures should be applied during the entire path of workflow that begins with the patient and ends in interpreting and reporting results.Many of the twelve quality system essentials overlap each other (i.e., there is a close relationship between documents and records, and information management). However, some specific meningitis laboratory quality assurance measures can be highlighted. Many of them are detailed again in the respective chapters of this manual. The laboratory should prepare an organizational chart that reflects the hierarchy and lines of authority with functions and responsibilities of each post. The current duties and responsibilities of staff should be specified in written job descriptions including training required and necessary experience. The director’s commitment is crucial. A quality manager should be designated to ensure the implementation and monitoring of the quality policies. Continuous education opportunities should be offered to the staff and recorded, especially if new tests or methods are introduced. Regular competency assessment and proficiency testing should be conducted and documented.Equipment manuals should be available in the laboratory area for easy reference. An inventory of equipment including records of maintenance and repair should be maintained.

If the lab performs testing on non-regulated analytes, the lab must have a method for verifying the accuracy of its test results. Proficiency testing or split sampling may be used. The fifth standard involves the relationship of patient information to patient test results. This is an internal quality assurance function. The lab must have a system in place to identify and evaluate patient test results when they appear inconsistent such criteria as the patient’s age, sex, diagnosis, and the relationship with other test results. The sixth standard involves personnel assessment. The laboratory must have a system in place to evaluate the effectiveness of its policies and procedures for assuring employee competence. The seventh standard involves communications. The lab must have a mechanism for documenting problems arising as a result of a breakdown in communication. Corrective actions must be taken to both resolve the problem and minimize future communication breakdowns. The eighth standard addresses complaint investigations. The lab must have a system to assure that all complaints and problems are documented. Investigations must be made and corrective action taken. The ninth standard is quality assurance review with staff. In addition to documenting and assessing problems identified in QA reviews, the lab personnel must discuss the issues and take corrective action to prevent recurrences. The tenth standard addresses QA records. Documentation of all QA activities must be made available to the Department of Health and Human Services. In the latter case, pleaseHow are we doing. Europe PMC is part of the ELIXIR infrastructureEurope PMC is a service of theIt includes content provided to the. CDC twenty four seven. Saving Lives, Protecting People In a medical laboratory, the quality can be defined as accuracy, reliability, and timeliness of the reported test results ( 1 ).

While internal QC primarily assesses the examination steps, other quality indicators can be designed to monitor the pre- and post-examination steps:This indicator provides information on the pre-examination performance. Customers’ satisfaction can be assessed by means of questionnaire, interviews, or meetings. A number of tools have been described above to identify errors, such as customer service surveys, internal QC, EQA, auditing, and quality indicators. A rigorous analysis of all of these indicators should lead to improvements in procedures and practices. These changes should be recorded and reflected in the SOPs and implemented in the laboratory. Open communication among staff members is also important to encourage suggestions that may improve the quality and efficiency of the laboratory. See Chapter 4: Biosafety. NCCLS document GP26-A3. NCCLS. Wayne, Pennsylvania. 2004. Geneva, Switzerland: International Organization for Standardization; 2007. Our news promotes the best new methodologies in science. Our news promotes the best new methodologies in science. It involves systems that safeguard the accuracy, reliability, and timeliness of lab results by ensuring the early detection of results or measurement errors and the procedures to rectify them. It should be performed regularly and quality control materials should be treated the same as samples, from the beginning to the end of the run. In addition, the QC measures developed in a lab are the building blocks for the process of certification and accreditation. This may include errors like sample mix-up, mislabeling, improper storage or transportation and unsuitable sample collection methods. For any potentially infectious or toxic sample, triple packaging rules outlined by the International Air Transport Association (IATA) regulations should be followed and proper warning labels attached. Samples that might undergo degradation could lead to false results.

The procedures should be written and implemented to assure that all reagents and supplies are correctly selected, purchased, used, and stored in a manner that preserves integrity and reliability. The inventory should be kept up to date including information on reception, storage, and issuance. Package inserts and Material Safety Data Sheets (MSDS) should be archived as part of records keeping. This manual should serve as a basis for writing the laboratory Standard Operating Procedures (SOPs) which need to be adapted to the laboratory’s role and capacity.See Chapter 3: Results Management and Reporting of Data for items that should be included in the request and report forms. Internal QC of specimen identification and characterization should include: QC should be performed quarterly as well as when a new lot is received in the laboratory. If access to QC strains is difficult, well-characterized clinical isolates confirmed and characterized in a reference laboratory (such as a WHO Collaborating Center) are available. Isolates received from another laboratory as part of a proficiency testing program received in the scope of External Quality Assessment Schemes can also be used. See Chapter 3: Results Management and Reporting of Data. A system is needed for detecting and documenting these occurrences, for handling them properly, and for taking corrective action to reduce the chance of recurrence. Common errors include: Ultimately, corrective actions should be implemented to prevent similar errors from recurring. Assessment may be internal, performed by the laboratory’s own staff, or may be external, conducted by an external group or agency outside the laboratory. There are three commonly used EQA methods or processes:The laboratory reports the results back to the organizer who will compare the test results with known results and record a pass (all results concordant) or fail (any discrepant results) for the PT.

The many benefits of a proper laboratory quality management system far outweigh the laborious design, set-up, and monitoring process and it is important for any analytical, diagnostic, or research lab to have one in place. NCCLS document GP26-A3. NCCLS. Wayne, Pennsylvania. 2004. Geneva, Switzerland: International Organization for Standardization; 2007 Please inquire about bulk order discounts. To view our SAM, or FBO credentials please contact us for our CAGE code and DUNS number. Conduct Science products and its suppliers are NOT designed for human consumption, testing, or clinical utilization. They are designed for pre-clinical utilization only. Track air quality and smoke forecasts at wasmoke.blogspot.com. This checklist can help you write or review a quality assurance manual for your lab. Before you submit your manual, use the following guide to review it. Keep in mind that not all points may apply to every lab. Use this checklist to guide your review of your own manual. Some points may not apply to smaller non-commercial labs. What was challenging.Your name: Phone number. Policies and procedures insure accurate reliable and prompt reporting of test results, as well as help to meet standards from regulating agencies. Ongoing quality assurance activities can detect errors, procedural lapses or divergences from goals, while also suggesting changes need in procedures or training. See the QUALITY CONTROL policy located in Section VI of the LAB MANUAL for specific descriptions of quality control materials and activities. Proficiency samples are handled in the same manner as patient samples. All testing personnel participate in analyzing proficiency samples. The medical director reviews all results and corrective actions (if needed). See the PROFICIENCY TESTING policy located in Section VI of the LAB MANUAL for more details of proficiency testing activities and monitoring. Training checklists and performance reviews are reviewed by the lab supervisor.

Performance reviews and competency checks are performed at 6 months for new staff, and annually thereafter. Moderate to highly complex testing is only performed by licensed clinical lab scientists, while waived testing is only performed by personnel that have successfully completed training. Phlebotomy is only performed by licensed phlebotomists or clinical lab scientists. See the LABORATORY STAFF ORIENTATION, TRAINING AND ASSESSMENT policy located in Section VI of the LAB MANUAL for more details. Abnormal or unexpected results are verified as needed. Any results questioned by the clinician are repeated and verified if possible. Critical results are called to clinicians within 30 minutes of final result. Critical result phone calls follow the format of using two forms of patient identification and having the recipient read-back the result. Documentation of the call is included in the medical record with the result. Corrected test results are called to the clinician as soon as possible. Documentation of corrected result calls is included in the medical record with the results. See the REVIEW OF TEST RESULTS policy located in Section VI of the LAB MANUAL for more details. Hand labeled specimens may be acceptable but must have at least two forms of identification. In this case, the Lab Supervisor notifies the Medical Director, or their designee, who messages all clinicians potentially affected by the discarded specimen. The validation consists of precision testing, correlation with a previously verified method and verification of linearity (if quantitative results are involved). Established instruments and methods are verified to be accurate through the use of Interlaboratory Quality Assurance Programs (IQAP) when available, quarterly proficiency testing and biannual calibration verification (where applicable).

Storing aliquots of test material provides back-up in cases of errors in downstream processes. This could be due to the use of the wrong test reagents, the use of defective and non-calibrated equipment, the use of the wrong proportions of reagents, and general non-adherence to standard operating procedures (SOPs). It encompasses both the managerial and technical aspects of the lab procedures. The goal of a laboratory QMS is to ensure that results are accurate, reliable, and obtained under a traceable process that can easily detect errors. In addition, there should be documentation showing the functions and duties of every lab member, their competencies, experience, training attended and training required. Capacity building by ensuring they undergo regular training and motivation, as well as proper handling of staff concern ensures optimal performance. There should be regular meetings between the management and all staff to disseminate information and discuss issues of concern. After its installation, members should be properly trained on the use of the new equipment. Equipment manuals should be easily accessible in the laboratory area for easy reference. The procedures should be written and implemented to ensure that all supplies are correctly selected. This involves all the pre-analytical, analytical, and post-analytical stages. Documentation should be availed for all parties and a coordination person or team in place to ensure a smooth workflow. The documents provide information about the laboratory’s policies, processes, and testing procedures and should be stored in the laboratory quality manual for each laboratory. An SOP should be written for all procedures in the laboratory, including specimen collection, transport, storage, and waste disposal. The laboratory must have provision for documentation of such errors and occurrences that may interfere with proper laboratory operations. It can be either internal or external assessment and audit.

The internal assessment is done by members of the lab and makes use of test controls like standards to validate the testing process and equipment. This is done through lab visits by the assessors to observe processes, validating tests by sending aliquots of test materials to the external assessment agency or having the assessing agency send in unknown material for testing in the lab. It involves all the corrective efforts made after the identification of points of errors and non-compliance. All actions should be documented, SOPs and QMS should be updated, and the changes in process and procedures should be communicated to the lab members. Ensure that the customer is able to freely give feedback through interviews, questionnaires or meetings and have access to a complaints medium. All customer feedback should be documented, analyzed, and used for process improvement. The laboratory management should ensure that all lab members are well-trained in safety requirements, SOPs, emergency response, and waste management. Different guidelines exist depending on the risk level of the lab. Detailed information on laboratory safety can be found here. The standards developing body may recognize an institution through three different processes. Various standards are provided under different categories, i.e. general quality management systems like the ISO 9001 certification that a lab can use to prove its proficiency. Third-party audits are done to evaluate the laboratory with the goal of attaining accreditation. When developing quality practices, ensure that all the lab’s processes and procedures are outlined so as to create a proper workflow with clear responsibilities. The lab management should make certain that the staff is actively involved in the development and implementation of the quality system to enhance compliance.

See procedures, EVALUATION OF AUTOMATED TEST METHODS, LINEARITY TESTING (REPORTABLE RANGE) CALIBRATION VERIFICATION, PROFICIENCY TESTING and QUALITY CONTROL AND ASSESSMENT in section VI of the Laboratory Manual for further information. These activities may be ongoing or may change periodically to meet the needs and the goals of lab management. It is desirable to decrease the TAT for testing that is needed urgently (STAT) so as to expedite patient care. Monitoring TAT can help facilitate corrective actions where the TAT does not meet goals and can lead to overall changes in procedures and personnel in order to maximize efficiencies. The lab will monitor STAT in-house CBCs and STAT urine dipsticks for TAT during the current year. The Lab Supervisor will notify the Medical Director, or their designee, who will message all clinicians potentially afffected by the discarded specimen. All erroneous lab results must be corrected and the clinician notified promptly. Such errors are documented in the problem log. The projects will ascertain to measure the quality of the process in terms of sensitivity, specificity or timeliness. It will also be assessed as to whether the process can be improved by implementing various changes or having staff focus on the issue. Examples of such past QI projects are the Wet Mount vs Trichomonas Culture project (improve sensitivity) or the Urine Leukocyte Esterase vs Manual WBC Count project (improve accuracy, sensitivity and utilization). Faster Solution Delivery. Compliance with FDA regulations and the CLIA amendments can be easily ensured with the implementation and use of MasterControl's clinical laboratory quality control software.The basic aim of this software is to integrate quality process management and to enable online cross communication between company departments.

MasterControl is the leading pioneer in providing web-based solutions to companies that need to streamline their business processes and operations with a single web-based platform. In order to help companies attain FDA compliance, MasterControl’s clinical laboratory quality assurance software provides validation tools and services. The entire validation solution is comprised of a combination of products and services that address different levels of validation needs. Organizations can either automate or manually validate their software solutions based on their risk assessment model. MasterControl's validation tools and services dramatically reduce the time involved in validating a system, reducing the risk of project implementation and making it easier to validate software upgrades, all of which help contribute to a lower cost of validation. The MasterControl suite consists of the following integrated applications: Clinical Laboratory Quality Control System for Document Control The biggest challenge faced by life science organizations including clinical and medical laboratories is inefficiency in their business operation units. Inefficiencies invariably hamper the effectiveness of a business's processes (and subsequently its products) and are not properly aligned and managed. Clinical Laboratory Quality Assurance Software and CAPA System Quality assurance is a major part of testing, analyzing and observing processes in the system. This ensures that any deviation or nonconformity from the standard is immediately reported. The MasterControl clinical laboratory quality assurance and CAPA system interconnects different quality subsystems and tracks incidents that can escalate into a corrective action. Since the software ensures integration between quality processes, a CAPA form can be launched directly from another form within the clinical laboratory quality assurance system (e.g, nonconformance or deviation report).

Relevant data is automatically entered into the CAPA form that reduces data entry and eliminates errors from the manual transfer of information. Clinical Laboratory Quality Control System for Change Control Success of any company lies in how quickly it adapts to change. Change control features streamline the entire change control procedure for faster turnaround. MasterControl’s clinical laboratory quality control system offers best-practice forms that incorporate priority levels and prompt risk assessments and classifications of the change as low, medium, or high. Any high-level change implies a great impact on the product and is likely to require regulatory filing. This is where MasterControl Documents helps in documenting the change that eliminates the risk of practicing business by following outdated procedures in the system. Customizable reports in our clinical laboratory quality control software provide real-time quality system data. Training Management in Clinical Laboratory Quality Assurance Systems The majority of life science companies spend valuable capital on hiring specialized teams of trainers to train employees about various aspects of the business. MasterControl's clinical laboratory quality assurance training system automates the assignment and monitoring of training tasks and the grading of online exams. It allows for the sequencing of training courses so that after a prerequisite course is complete the next one can be automatically launched. This helps in training large numbers of employees in training programs verified by the group sign-off feature. Training management can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change. Companies can allocate internal resources and save capital that can be used in other areas of the business.

Clinical Laboratory Quality Assurance System and Nonconformance Automation Software Emphasis on compliance has enabled life science companies from across the globe to build their business so that it adheres to FDA regulations. Adherence to FDA regulations can lead to nonconformance events and severe consequences for companies. A critical eye for catching any anomalies is the basic requirement of any business. Because of this reason, MasterControl has devised a robust clinical laboratory quality assurance and nonconformance automation software solution that will automate, manage, and streamline a process for identifying, evaluating, reviewing, and handling nonconformance materials, components, parts and finished products. The solution's best-practice form and five-step process connects all responsible personnel for the effective and timely disposition of a nonconformance. Depending on the size of a business, the company can choose to maintain a standalone nonconformance process for small-scale, localized incidents, or may choose to connect it to the CAPA process, which will trigger automated escalations when the situation is warranted. The training solutions will automatically invoke training tasks upon approval of a document change (e.g, an SOP) or when specified by a training manager. Clinical Laboratory Quality Control Software and Audit Management System Companies that handle multiple and intricate kinds of procedures often require large amounts of documentation. Over time, it becomes increasingly difficult to maintain all of the documentation especially as a good portion of that documentation is updated and results in new document versions. This poses problems as multiple version of the same document are often left circulating among employees. The company may run the risk of a serious nonconformance event and may even have to temporarily shut down a specific manufacturing unit from production.

MasterControl clinical laboratory quality control software solutions and audit management systems automate, streamline and effectively manage the audit process. It provides advanced tracking capabilities, from scheduling and planning to execution, completion and reporting. Apart from this, the advanced reporting feature helps in analyzing different dimensions of the business so managers can get a real-time view of the audit process. Clinical Laboratory Quality Control Systems and Customer Complaints Software Companies want to be able to process customer complaints in an effective manner so that a resolution of these complaints can occur without excessive delay. MasterControl's clinical laboratory quality control and customer complaints software streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. The solution provides a three-step process that starts with the processing of a customer complaint through the web-based portal, automatically moving to internal investigation and culminating with a resolution of the issue. In order to resolve issues, top-level management can generate reports and analyze the root cause of the problem with increased oversight. Form-Based Clinical Laboratory Quality Control Software MasterControl's clinical laboratory quality control software is a forms-based quality system which automates routing, notification, escalation, and approval of any forms-based process for faster turnaround. One big advantage of the forms-based clinical laboratory quality control system is that it offers best practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Forms created in Microsoft Word, Excel, or PowerPoint can be converted to HTML, so users will see the same form and won't need new training. It is based on the discretion of the company to either improve existing forms or design new ones to suit specified company needs.