clinical lab quality manual

I did and I am more than satisfied.He now uses the Demolisher system to generate income.Research and development services are not applicableas supposed to the nature of services provided. This document applies to all COMPANY XYZsites including Quality System, Medical Laboratories (Central United Medical Laboratory (CUML)and International Clinic Laboratory (ICL)), Al Seef Hospital, Dental Laboratory (Central UnitedDental Laboratory (CUDL)) and any projected premises for COMPANY XYZ in the future.Our goal is to achieve thehighest level of client satisfaction.Aid in the diagnosis, treatment, and monitoring of the health status of our patients. ? Developing, sharing, and implementing disease management strategies to reduce overall costs and improve patient care. ? Lowering unit costs by sharing, standardizing and integrating laboratory services. ? Increasing revenues through enhanced outreach services. ? Successfully competing for managed care contracts for laboratory services.2.2 VISION:To serve as a wide-reference company for Kuwait and Gulf region that provides laboratory testingand consultation in the health care sector. ? Diagnostic services leadership in the Private health care of Kuwait. ? A single, influential, educational laboratory with an entrepreneurial approach. High quality patient care through effective and efficient use of laboratory resources. Maximal provision of specialized and reference clinical laboratory services for the country. ? Responsive to changing clinical, service, education, technological and fiscal needs. Commercialized applied research and internationally recognized expertise. Balance between generalists and specialists. Serve as a Kuwait -wide reference company for laboratory testing and consultation UNCONTROLLED DOCUMENT IF PRINTED It also provides comprehensive and cost effective diagnostic services whichbalance the needs of clinical programs with the resources of laboratory medicine.

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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. It also provides opportunity of checking whether the quality system is implemented in reality and demonstrates to the hospital administration and the clinicians that the laboratory is committed to quality. The intention of these guidelines is to describe the elements of the quality system for a large clinical laboratory, and to presentate such a system in the form of a quality manual. However, information about the minimum requirements for official recognition should be obtained from the particular accreditation or certification body concerned. Key Words: accreditation, audit, certification of quality system, good laboratory practice, quality improvement, quality management, quality manual, quality system To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy. By closing this message, you are consenting to our use of cookies. If you continue browsing the site, you agree to the use of cookies on this website. See our User Agreement and Privacy Policy.If you continue browsing the site, you agree to the use of cookies on this website. See our Privacy Policy and User Agreement for details.If you wish to opt out, please close your SlideShare account. Learn more. You can change your ad preferences anytime. I can promise you 100% un-plagiarized text and good experts there. Use with pleasure! ? www.WritePaper.info ?I sent a request to ? www.HelpWriting.net ? and found a writer within a few minutes. Because I had to move house and I literally didn’t have any time to sit on a computer for many hours every evening. Thankfully, the writer I chose followed my instructions to the letter. I know we can all write essays ourselves. For those in the same situation I was in, I recommend ? www.HelpWriting.net ?.HelpWriting.net ? ?

QC can beconsidered part of the operational control of processes, being extremely useful fordetecting and correcting real and potential deviations. COMPANY XYZ currentlyparticipates in inter-laboratory comparison ?proficiency testing program.The report is electronic and could be written.COMPANY XYZ have developed a typical report format which comply with the needs ofusers, clear and unambiguous and enables the user to interpret the results. The reportshall be as follows:.Clear identification of the examination. ? time and date of report.Once a problem occurs, labmanagement takes into consideration first to document the problem, and assign adesignate for problem solving.QAManager develops the audit plan annually, taking into consideration the status andimportance of the activities and areas to be audited as well as the results of previousaudits. The audit plan is revised after each audit and updated if needed. The audit criteria,scope, frequency and methods are defined.Audits are conducted by personnel other than those who perform the activity beingaudited. LIMS is very crucial to the lab where it serves as a tool fortracking all tasks related to primary samples from receiving, collecting, testing, retesting,and reporting test results. Medical Lab and dental staff at COMPANYXYZ shall. Maintain strict confidentiality of patient information and test results. ? Be accountable for the quality and integrity of the services and tests they provide. ? Exercise sound judgment in conducting, and evaluating laboratory testing. ? Maintain a reputation of honesty, integrity and reliability with respect to profession.Medical laboratories — Particular requirements for quality and competence ISO 15189:2007(E). NCCLS A Quality System Model for Health Care; Approved Guideline Vol. 19 No. 20 ? Quality Management Systems -- Requirements ISO 9001 Fourth edition. COMPANY XYZ Business Process Interaction, refer to C. Confidentiality Agreement.

As a result, COMPANY XYZ provides optimal patient care in the clinical and dental fields.COMPANY XYZ became accredited by the College American of Pathologists (CAP) in 2007 (Firstin Kuwait).COMPANY XYZ became accredited under ISO 15189:2007 in 2009.Moreover department managers should:.QA is defined as a program that guarantees quality patientcare by tracking outcomes through scheduled reviews.Management iscommitted to solving health and safety problems in a co-operative approach withemployees, to performing workplace inspections, monitoring on the-job safetyperformance, auditing for health and safety program success, and is committed to theprocess of continuous improvement in health and safety performance.COMPANY XYZ is committed to training and motivating employees for safety performanceand to sustaining and updating their safety knowledge.Proper preparation of the patient,specimen collection and handling are essential for the production of valid results by alaboratory.Prior to, during and after executing the medical testing of the specimen collected the labstaff shall: a. Check the completion of the request form and confirming the identity of the patient b. Verify that the specimen container is labeled correctly c. Ensure that the patient is appropriately prepared d. Ensure that the specimen is collected correctly e. Exercise precautions and awareness of risk of interchange of samples f. Ensure that environmental and storage conditions are fulfilled g. Ensure the safe disposal of all materials used in specimen collection h. Ensure that all spillages and breakages are dealt with correctlyThese procedures for specimen collection are available for the phlebotomist and all otherstaff in the hematology departments.In addition COMPANY XYZ All test report results shall be reviewed andvalidated by Medical director at COMPANY XYZ. Laboratory staff shall first review theresults and ensure no discrepancies or deficiencies are observed.

Some tips include: This system is an abbreviated form; it should contain the first six elements from Table 1. A copy of each card should be included in the actual procedure manual. Sources: NCCLS Document GP2-A3, Clinical Laboratory Technical Procedure Manuals, 3rd ed.; The New Poor Man's (Person's) Guide to the Regulations, Laessig and Ehrmeyer. 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. 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.

Now customize the name of a clipboard to store your clips. Environmental Conditions 5.3 Laboratory Equipment, Reagents, and Consumables 5.4 Pre-examination Processes 5.5 Examination Processes TheSenior Management and Staff of. XYZ Laboratory also undertake to ensure that all activities areThe quality document structure containsRecords. XYZ Company. All agreements are reviewed and accepted only ifThis includes informing the client of anyAgreements Review Procedure. This procedureThe record states whetherLaboratory takes into account these factors in developing test andProcedure is applied for estimating uncertainty ofReasonable estimation is based on knowledge ofRequirements of the test method. Requirements of the client The. Its purpose is to ensure consistency while striving for quality. The procedure manual may be used to: It is advisable to include a page at the front of the manual where personnel can “sign-off” when they have read the manual. An annual review would benefit the lab personnel and could be included as part of the overall quality assurance program. Include a general policies section addressing lab-specific issues, such as: The manual must be readily available and followed by laboratory personnel. Textbooks may be used in addition to the procedure manual. The following information is required to be included (CLIA regulations, Subpart K, 493.1211): All procedures must be approved, signed, and dated by the laboratory director. Procedures must be re-approved, signed and dated if the director of the laboratory changes; each change must be approved, signed, and dated by the current laboratory director. The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance, retaining records for two years after the procedure has been discontinued. It is worth a little extra effort to make sure that it is useful. The design should be determined by the lab’s needs and organization.

They are designed for pre-clinical utilization only. 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 ). 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. 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.

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. 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.

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. 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. With a firm understanding of the 12 essentials of quality management in laboratory environments, you'll be able to confidently lead your medical services team to new levels of excellence and avoid potentially life-threatening mistakes. The concepts first used in medieval European guilds have been solidified and refined over the centuries into what is now known as quality management systems. The quality management system (QMS) model has been adapted to the medical laboratory environment resulting in a dozen essentials that form the framework for quality. The model for the following 12 essentials is from the Clinical and Laboratory Standards Institute (CLSI) and ISO 15189.

The management team and quality unit play an integral role in a quality-driven culture, along with structures for monitoring ongoing quality. Training, motivation, and engagement are key parts of the quality management system. Inventory activities should verify that materials and supplies are stored in a way that protects integrity. This data needs to be managed in a way that ensures all information is accurate, secure, confidential, and accessible to individuals with the right privileges, such as lab managers and leadership. One of the most essential lab documents is standard operating procedures (SOPs) to create a standard for each process. Documents need to be available at the point of work, maintained, accurate, and secure. A QMS software can help you detect these issues and facilitate investigations to discover the root cause and prevent reoccurrence. Assessments include the activities of lab or QC managers, internal auditors, or external inspectors. Components of the QMS which support improvement can include QC and CAPA (occurrence management). A laboratory’s QMS should support operations that consistently provide a positive customer experience through the production of consistently high-quality products or other missions. The laboratory needs to understand the customers and their needs and use customer feedback for improvement. This includes physically securing the lab, containment procedures for hazards, worker safety, and ergonomics. If your QMS is missing several elements, such as document control or physical security, the entire system can easily crumble. Similarly, if your QMS hits all the basics but you can’t coordinate between the essentials by understanding the bigger picture of quality trends or root causes, you’re at risk of error. The right software can help you avoid having to reinvent the wheel by building a QMS from the ground up. Maintaining coordinated quality processes with paper systems can lead to poor visibility and human error.

It includes all the essentials to help fast-growing lab startups and scale-ups create a solid quality baseline. Learn more about our solution here. The term is usually used with products and services. As an objective characteristic, quality is not measurable but interpretable. In the testing laboratory, quality is interpreted as compliance with specifications. Therefore, quality means that the laboratory results meet the customer’s expectations and are accurate and defensible. Historically, as production methods transitioned from individual producers to factories, mass production of goods incorporated automation and process control. Walter Shewhart was the inventor of statistical process control (SPC) and developed the Shewhart cycle. The cycle contains four continuous steps—plan, do, check and act (PDCA). With consistent utilization, the PDCA control circuit leads to continuous improvement. William Edwards Deming expanded on Shewhart’s ideas by defining a systematic approach for continuous improvement through constant evaluation and employee involvement that would improve production processes by setting and achieving increasingly higher standards. Within Europe and the U.S., the process of developing the quality management function within a company started in the early 1970s and is now close to maturity. Management, Assurance and Control Quality management works on the organizational level to implement an overall quality policy. A quality system refers to the organizational resources, processes and procedures to implement quality management, which is broader than both quality assurance (QA) and quality control (QC). However, a QA program is the backbone of the laboratory quality system. The relationship between the quality system, QA and QC is as shown in Figure 1. QA provides a management tool within the organization. In contractual settings, QA provides confidence to the customer. QC is a process within the QA program.

The process is to collect evidence that the desired level of quality is achieved, and the process itself has no impact on the product quality. Besides QA, the laboratory quality management system also includes management of equipment, supplies and inventories, management of capital, finances and budgeting, and providing training and continuous support of staff and customer service. Essential Tools for QA To ensure that the final laboratory results are correct, the QA program incorporates those planned and systematic laboratory activities that guarantee the accuracy and defensibility of testing results. The quality manual, Standard Operating Procedures (SOPs) and documentation are essential components of a QA program. The quality manual refers to the master document of the laboratory quality policy and serves as the primary resource for laboratory information. The management team is responsibile for ensuring adherence to the laboratory quality manual, QA plan and SOPs. Other supplementary records (e.g., instrument logbooks, reporting forms) are also critical components in a QA program. In the controlled environment of a testing laboratory, if the activity is not documented, then the activity never happened. Besides thorough documentation of all procedures and processes, the laboratory also needs to choose the correct methods for testing and establish protocols to detect errors and initiate corrective actions. Validated methods are at the technical core of laboratory testing. To determine whether methods are fit for their intended purpose, the selected methods must have established accuracy, precision, calibration and limits of detection and quantification. For methods that are taken from a recognized resource, usually a verification process is sufficient to establish the method performance for the lab. However, if the analytical method is developed in-house, a full validation is required.

Audits are conducted to verify conformance to the requirements of the quality system. The audit is a tool to assess the effectiveness of the quality system and to identify places for future improvement in laboratory process and personnel performance. Internal audits need to be conducted at appropriate and practical intervals. Typically, the QA manager is responsible for performing the internal audits to address all elements of the quality management system, analytical activities, records and documentation. Auditing activities could include reviewing SOPs, worksheets, lab notebooks, balance calibration records, working control data, pipette calibration records, equipment monitoring logs and other related items for producing test results. The auditor typically uses a checklist to determine the auditing scope and content. QC refers to a measuring process, or to check a result and provide assurance that all activities are performing within predetermined limits. One of the key QC processes in any laboratory is SPC, which utilizes statistical methods to evaluate variability in the laboratory testing and the stability of laboratory procedures. Control charts are the most commonly adopted tools to monitor the testing procedures. They are often generated by calculating the long-term mean and range by averaging multiple sets of experimental duplicates over time. By doing such calculations, the laboratory can establish an expected average and variation for future comparison. Control charts thus provide a standard against which the stability of the lab performance can be evaluated. Other QC procedures that ensure that the laboratory results are of required quality include instrument calibration, use of reference materials, repeated analyses and sample and reagent blank analyses. Traceability, uncertainty and proficiency testing are the three major items to be addressed in a QA program.