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clinical laboratory quality control manual
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clinical laboratory quality control manual
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.
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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. 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. In addition, there should be documentation showing the functions and duties of every lab member, their competencies, experience, training attended and training required.
The integrity of quality control samples is important to both management of overall quality as well as to meeting requirements of proficiency testing. Addressing QC issues is critical to the identification of potential errors with patient results, including reagent matrix effects as well as calibration misalignment of testing function. Maintaining accurate and frequent checks of laboratory sample testing through quality control is vital to ensuring that patient testing is done right and that it produces accurate results. According to Ibrahim et al., 1 failure of QC testing can result from “clerical, methodological, technical, PT materials stability, and random errors.” By utilizing quality control practices, a laboratory self-regulates its testing and verifies that the results produced are accurate and precise. Clinical labs use management of documentation as well as incorporation of a continuous improvement process to streamline the overall quality control process. Precision is the “degree of agreement among repeated measurements of the same characteristic on the same sample,” 3 while accuracy is how close results are to what is expected from a test. These results would indicate a low bias result in the instrument. Clinical laboratories are frequently enrolled in clinical laboratory proficiency testing (PT) programs that are used to validate their testing protocols. These programs, for example those through the College of American Pathologists (CAP), are utilized not only to validate laboratory testing but to validate personnel training and procedures. 1 CAP’s PT program utilizes samples identical to patient samples and not only validates individual laboratories but utilizes peer comparison to generate more accurate ranges for proficiency samples. Periodic review of QC results is a frequent tool for maintaining quality control of patient samples.
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. They are designed for pre-clinical utilization only.
Data tracking then showed a sudden spike in values for one level of QC and a sudden drop in the other level of QC, even though both sets of QC were within range ( Figure 1 ). The company investigated the claim and substantiated it. Shortly thereafter, the company issued a technical bulletin advising laboratories to avoid using the third party’s QC materials until the bias could be resolved. The laboratory used a different company’s QC materials, and values returned to the ranges seen before the matrix effect. The lableadership was relieved to learn that the bias effect only affected quality control materials and not patient results. The focus on trends and biases is a good identification of potential changes in results that can affect accuracy of overall results. Also, management of matrix effects and calibration misalignment are important aspects to observing shifting L-J charts and adjustments of accuracy over time. Continuous monitoring of quality control testing and capture of biases or trends are important to ensure accuracy of patient testing results. As laboratorians, our function as managers is as valuable to the patients as our ability to analyze their samples. Good clinical laboratory practices improved proficiency testing performance at clinical trials centers in Ghana and Burkina Faso. PLOS One.2012;7(6):1-7. Annals of Laboratory Medicine. 2014;34(4):274-278. The volunteer monitors guide to quality assurance project plans. Chapter 3.. Accessed November 26, 2014. Implementing self-sustained quality control procedures in a clinical laboratory. Journal of Nepal Medical Association. 2013;52(189):233-237. Commutability Limitations Influence Quality Control Results with Different Reagent Lots. Clinical Chemistry. 2011;57(1):76-83. National library of medicine. National institutes of health.. Accessed November 26, 2014. All rights reserved. Its purpose is to ensure consistency while striving for quality.
In early 2014, several laboratories using the same clinical chemistry analyzer failed a CAP PT survey for Hemoglobin A1Cs (HbA1C). Although the peer data showed that these laboratories were precise with each other based on the data generated, CAP reported that these laboratories had failed the survey. Investigation among the laboratories showed that controls were well within established parameters and calibrations were valid. The laboratories queried the analyzer manufacturer and expressed concerns over reagent quality. The company conducted its own internal investigation and discovered that the reagent would cause results to be 0.4% to 1.0% higher than what should be resulted. The company contacted the FDA and issued a technical bulletin alerting laboratories that patient results could be erroneous, even though calibrators and controls worked as intended. The laboratories contacted patient providers and thousands of patients so that patients could be assessed and retested. An L-J chart and the Westgard Rules are frequently used to verify trends, biases, or errors in quality controls. The Westgard Rules observe the normal distribution expected and identify standard deviations produced. 4-5 Implementing Westgard rules within an L-J chart can identify violation of the rules based on control limits established for the sample tested. While daily identification of QC deviations from normal ranges ensures accuracy of sample testing, longer-term reviews are more beneficial to diagnose trends and biases in tests which could be missed on a daily basis. An additional use of the L-J chart without quality control samples is to utilize patient samples as their own controls. 6 By tracking the running averages of the patient results, a laboratorian can identify drift or problems with analyzer function that are not captured by quality control testing. Addressing concerns with QC materials as well as recall issues are common challenges for laboratory managers.
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). 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). Quality assurance will check the entire testing process and will check quality regularly. This is difficult to define the true value of a substance.A method may give excellent precision but poor accuracy. It is not affected by extreme values. This may be caused by:Problems arise from imperfect procedures which are 85 %. Remaining 15% of problems needs action and performance improvements of individual employees. So the main problems are management problems and management has the power to change the work process. Barcode technology has reduced these mistakes which are common in the handwritten labels. All informations are useful for doctors, lab technicians, nurses, and paramedical staff. All the tests include details about the sampling, normal values, precautions, pathophysiology, and interpretation. 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. A reference list for that course was created. We still make this available for those interested. Also included are some earlier references concerning the performance characteristics of QC procedures and the evaluation of analytical methods that help complete the background for this approach to analytical quality management. Implementing Total Quality Management in health care laboratories.Quality management science in clinical chemistry: A dynamic framework for continuous improvement. Clin Chem 1990;36:1712-16. Beyond quality assurance: Committing to quality improvement. Laboratory Medicine 1989;20:241-7. Total Quality Control: Evolution of quality systems in health care laboratories. Laboratory Medicine 1989;20:377-84.
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. 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. Refer to the downloads and the related links sections below for the State Operations Manual and additional educational information. 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.
Cost-Effective Quality Control: Managing the quality and productivity of analytical processes. AACC Press, Washington, DC, 240 p, 1986 (chapter 1). Manual of Clinical Laboratory Immunology, 5th edition, Rose NR et al ed, ASM Press, Washington, DC, 1997, pp 1191-1200. Westgard JO, QA: Are laboratories assuring, assessing, or assuming the quality of clinical testing today. Proceedings of the CDC 1995 Institute on Critical Issues in Health Laboratory Practice: Frontiers in Laboratory Practice Research. CDC, Atlanta, GA, 1996, pp 179-189. Westgard JO, Klee GG. Quality Assurance. Chapter in Fundamentals of Clinical Chemistry, 2nd ed, Burtis K, ed., WB Saunders Company, Philadelphia, 1996, pp. 211-223. Westgard JO. Strategies for Cost-Effective QC. Clin Lab News 1996;22(10): 8-9. Westgard JO. A method evaluation decision chart (MEDx Chart) for judging method performance. Clin Lab Science. 1995;8:277-83. Westgard JO. A QC planning process for selecting and validating statistical QC procedures. Reviews in Clinical Biochemistry 1994;15(iv):155-64. Westgard JO, Klee GG. Quality Assurance. Chapter 2E in Textbook of Clinical Chemistry, 2nd edition. Burtis K, ed., WB Saunders Company, Philadelphia, 1994, pp 548-592. Burnett RW, Westgard JO. Selection of measurement and control procedures to satisfy HCFA requirements and provide cost-effective operation. Arch Pathol Lab Med 1992;116:777-782. Westgard JO. Analytical quality assurance through process planning and quality control. Arch Pathol Lab Med 1992;116:765-769. Westgard JO, Burnett RW. Precision requirements for cost-effective operation of analytical processes. Clin Chem 1990;36:1629-32. Westgard JO and Barry PL. Cost- Effective Quality Control. Japanese edition, 1989. Westgard JO, Barry PL. Cost-Effective Quality Control: Managing the quality and productivity of analytical processes. AACC Press, Washington, DC, 240 p, 1986 (chapters 2- 5). Westgard JO, Groth T.
A predictive value model for quality control: Effects of the prevalence of errors on the performance of control procedures. Am J Clin Pathol 1983;80:49-56.What is the quality of quality control procedures. Scand J Clin Lab Invest 1981;41:1-14. Clin Chem 1997;43:400-403. Clin Chem 1996;42:1683-1688. Clin Lab Manag Review 1996;10:377- 403. Ogunquit, ME, Westgard QC, 1996, distributed by American Association for Clinical Med Lab Observ 1994;26(2): 55-60. Cholesterol - a model system to relate medical needs with analytical performance. Clin Chem 1993;39:1504-1513. Clin Chem 1992;38:2256-60. Clin Chem 1992;38:1226-33. Clin Chem 1992;38:175-8. Cholesterol operational process specifications for assuring the quality required by CLIA proficiency testing. Clin Chem 1991;37:1938-44. Laboratory process specifications for assuring quality in the U.S. National Cholesterol Education Program (NCEP). Clin Chem 1991:37:656- 661. Relationship of quality goals and measurement performance to the selection of QC procedures for multi-test hematology analyzers. Eur J Hem 1990;45 suppl.53:14-18. QC selection grids for planning QC procedures. Clin Lab Sci 1990;3:271-8. Clin Chem 1981;27:1536-1545. An interactive computer simulation program for the design of statistical control procedures in clinical chemistry. Computer Programs in Biomedicine 1981;13:73-86. Clin Chem 1979;25:863-69. Laboratory precision performance: State of the art versus operating specifications that assure the analytical quality required by proficiency testing criteria. Arch Path Lab Med 1996;120:621-625. Matrix effects on the performance and selection of QC procedures to monitor PO2 in blood gas measurements. Clin Chem 1996;42:392-6. QC for immunoassays.Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria. Clin Chem 1994;40;1909-14. European specifications for imprecision and inaccuracy compared with operating specifications that assure the quality required by U.S.
CLIA proficiency testing criteria. Clin Chem 1994;40:1228-32. Planning QC procedures for immunoassays. J Clin Immunoassay 1994;17:216-22. Establishing and evaluating QC acceptability criteria. Med Lab Observ 1994;26(2):22-26. Predicting effects of QC practices on the cost-effective operation of a multitest analytical system. Clin Chem 1990;36:1760-64. Selection of medically useful QC procedures for individual tests on a multi-test analytical system. Clin Chem 1990;36:230-3. Performance characteristics of some statistical quality control rules for radioimmunoassay. J. Clin Immunoassay 1985;8:245-252. Quality control of multichannel hematology analyzers: Evaluation of Bull's algorithm. Am J Clin Path 1985;83:337-345. Assessment of 'Average of Normals' quality control procedures and guidelines for implementation. Am J Clin Pathol 1984;81:492-499. Quality control of electrolyte analyzers: Evaluation of the anion gap average. Am J Clin Pathol 1984;81:219-223. Use of anion gap for quality control of electrolyte analyzers. Am J Clin Pathol 1983;79:688-696. Clin Chem 1981;27:493-501. Clin Chem 1979;25:394-400. Clin Chem 1977;23:1881-87. Clin Chem 1977;23:1857-67. CRC Critical Reviews in Clinical Laboratory Sciences 1981;13:283-330. Method Evaluation, Japanese edition. Ishiyaku Publishers, Inc., Tokyo, Japan, 113 pages, 1981. DuPont aca III performance as tested according to NCCLS guidelines. Clin Chem 1979;25:1730-38. Statistical analysis of method comparison data: Testing normality. Am J Clin Pathol 1979;72:21-26. Method Evaluation. American Society for Medical Technology, 75p, 1978. Concepts and practices in the evaluation of clinical chemistry methods. Part V. Applications. Am J Med Technol 1978;44:803-13. Concepts and practices in the evaluation of clinical chemistry methods. Part V. Decisions on acceptability.Am J Med Technol 1978;44:727-42. Concepts and practices in the evaluation of clinical chemistry methods. Part III. Statistics. Am J Med Technol 1978;44:552-70.
Concepts and practices in the evaluation of clinical chemistry methods. Part II. Experimental procedures. Am J Med Technol 1978;44:420-430. Concepts and practices in the evaluation of clinical chemistry methods. Part I. Background and approach. Am J Med Technol 1978;44:290-300. Performance studies on the Technicon SMAC analyzer: Precision and comparison of values with methods in routine laboratory service. Clin Chem 1976;22:489-96. Clin Chem 1974;20:825-33. Clin Chem 1973;19:49-57. The goal is to maintain high quality and dependability. Labs may also use quality control to manage costs and employee schedules effectively. This includes internal and external auditing for extra safety and assurance. Firms specializing in laboratory quality control make their services available to labs in a variety of settings. Individual lab technicians must follow very precise procedures when performing and reporting tests. This is a key part of quality control for consistency. They also routinely calibrate and check lab equipment to make sure it is working properly, as well as maintain logs to show that this has been done and provide information about the results. Lab employees may also log the process of testing so that documentation is available in the event of an audit. Internal auditing procedures for laboratory quality control can include repeating tests to see if the results are the same, looking over documentation paperwork to determine if employees are conducting tests properly, and checking lab equipment to make sure it is working right. These may be performed by a supervisor or quality control officer. Internal protections also include issuing clear and detailed employee manuals for use by lab staff. External audits can involve repeating tests at different facilities, hiring technicians to calibrate and check equipment, and asking quality control officers to look over laboratory records and procedures.
This process can include the use of a consultant to make sure a lab is using the most up to date standards for all its testing and reporting practices. The law may require labs to submit to inspection by government agencies for the purpose of laboratory quality assurance. The inspector will write up any potential violations and concerns, identifying areas where the lab needs improvement. Laboratory quality control at labs handling forensic evidence also includes an extra layer of precautions to protect the integrity of evidence. These labs not only need to perform tests accurately, they also need to follow the rules of evidence to prevent a situation where evidence and test results may be excluded from court because the lab didn’t follow procedure. This includes training personnel in chain of custody procedures, having a secure area for evidence storage, and using clear labeling and tracking systems to monitor evidence in the lab at all times. Reference: www.wisegeek.com Randox Laboratories is one of the largest manufacturers of Quality Controls in the world, whether it is their own branded Acusera portfolio of controls and calibrators, or customised material for individual laboratories, research organisations, External Quality Assessment or Proficiency Testing schemes. Tweet Leave a Reply Cancel Your email address will not be published. A confirmation email will be sent to you. All Rights Reserved. The purpose of including quality control samples in analytical runs is to evaluate the reliability of a method by assaying a stable material that resembles patient samples.Quality control is a measure of precision or how well the measurement system reproduces the same result over time and under varying operating conditions.Pathologists need to be involved in development of quality control protocols, the selection of quality control materials, long term review of quality control data, and decisions about repeating patient samples after large runs are rejected.
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clinical laboratory quality management manual
Download Link: ➡ clinical laboratory quality management manual
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clinical laboratory quality management manual
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.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.
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This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. The handbook is linked to the training toolkit on laboratory quality management system. 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. 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 ? ? 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. ?
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.Now customize the name of a clipboard to store your clips. 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.
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. 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.
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. Open Access is an initiative that aims to make scientific research freely available to all. To date our community has made over 100 million downloads. It’s based on principles of collaboration, unobstructed discovery, and, most importantly, scientific progression.
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. In order to navigate out of this carousel please use your heading shortcut key to navigate to the next or previous heading. 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. 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.
General requirements for the competence of testing and calibration laboratories (Geneva: International Organization for Standardization) ISO 15189:2012. Medical laboratories—requirements for quality and competence (Geneva: International Organization for Standardization) Accreditation is an additional level in quality than certification. Anyway, ISO standards are voluntary norms at an international level and were created in order to standardize different activities to achieve high-quality products and services. However, accreditation is already a requirement in different government agencies for laboratory registration. Therefore, voluntary norms can become enforced in some countries and in some productive sectors. Other important international standards for laboratories have been developed and provided by the Clinical and Laboratory Standards Institute (CLSI) by means of a consensus process from many stakeholders including the global laboratory community. These CLSI consensus-based medical laboratory standards are addressed to continually improve the testing quality, safety, and efficacy promoting medical care excellence. Good laboratory practices (GLPs) represent a quality management system related with organizational processes and normalized conditions, under which nonclinical health and environmental safety studies are planned, performed, controlled, recorded, archived, and informed. The main objectives of GLPs are: Resources optimization People, environment, and experimentation animals’ protection Establishment of standardized operating methods To guarantee the quality and reproducibility of study results However, GLPs is not focused on the continuous improvement. This standard is used by laboratories that want to develop and implement a quality management system for their services and to achieve laboratory accreditation. It establishes a model for the evaluation of the technical competence of the laboratory through a third-party audit.
ISO 17025 applies to all laboratories, regardless of the number of employees or the extent of the scope of testing or calibration activities and either for other organizations or individuals or their own organization. It covers tests based on standardized, non-standardized, or laboratory-developed methods. ISO 17025 is formed by two groups of requirements: Management requirements: very similar to ISO 9001, they are related with the quality management of the laboratory. Technical requirements: aspects that influence directly on the results of laboratory testing and calibration activities. They are technically competent. They have the capacity to produce technically valid results. In the same way that ISO 17025, this standard does not certify but accredits specific testing techniques in function of the laboratory needs. Achieving ISO 15189, clinical laboratories demonstrate in an objective way and accredit that they have the necessary quality and technical competence, with a correct functioning of the laboratory. In other words, those factors that contribute to the accuracy, reliability, and validity of tests and calibrations, such as the staff, environmental conditions, equipment, or samples, must be recorded. These requirements related to human resource management (specifically in terms of qualification and competence or infrastructure (to guarantee test conditions) are due to test and calibration specificity and sensitivity. ISO 15189 extends also its scope to analytical, pre-analytical, and post-analytical phases to establish interaction mechanisms between patients, medical staff, and the laboratory. Figure 1 shows the similarities and differences between certification and accreditation. Figure 1. Similarities and differences between certification and accreditation.
As PhD students, we found it difficult to access the research we needed, so we decided to create a new Open Access publisher that levels the playing field for scientists across the world. How? By making research easy to access, and puts the academic needs of the researchers before the business interests of publishers. Our authors and editors We are a community of more than 103,000 authors and editors from 3,291 institutions spanning 160 countries, including Nobel Prize winners and some of the world’s most-cited researchers. Publishing on IntechOpen allows authors to earn citations and find new collaborators, meaning more people see your work not only from your own field of study, but from other related fields too. Content Alerts Brief introduction to this section that descibes Open Access especially from an IntechOpen perspective How it works Manage preferences Contact Want to get in touch. Contact our London head office or media team here Careers Our team is growing all the time, so we’re always on the lookout for smart people who want to help us reshape the world of scientific publishing. There are different standards that establish requirements for the implementation of a quality management system for laboratories, and a cross comparison between them is shown. Additionally, external quality assurance or assessment (EQA) programs offer multiple benefits to laboratories: method validation, comparing of results with other laboratories, testing problem identification, accreditation requirement compliance, and credibility. In order to control the quality of the procedures, these programs are a tool to keep the laboratory procedures and every variable involved in (staff, equipment, and method) well controlled. In the frame of a quality management system, benefits from external quality assurance programs are discussed, and different available designs are reviewed.
On the other hand, previous benefits will be real only if reported results for each program are analyzed in detail. Because additional advantages are achieved when the EQA results are integrated in the quality management system of the laboratory, a procedure is proposed. In addition, results from external quality assurance programs corroborate the usefulness of internal controls implemented by the laboratory as part of its quality management system. An alternative definition of a QMS is through the meaning of each word separately, according to the ISO 9000:2015 quality management system—fundamentals and vocabulary: System: a set of interrelated or interacting elements. Management: coordinated activities to direct and control an organization. Quality: degree in which a set of inherent characteristics of an object (product, service, process, person, resource, etc.) meet the requirements (established need or expectation, generally implicit or mandatory). We can conclude from these three sentences that the business, planning, and control activities performed on a set of elements to achieve quality represent a QMS. Many processes are performed in laboratories to guarantee the accuracy, reliability, and traceability of the results, avoiding that any error affects its users. All those processes make a necessary quality management system that controls, detects, and tracks them. 2. International standards for laboratories Requirements from ISO 9001 for the quality management system implementation and certification are the most widely international standards used by laboratories. ISO 9000 documents provide guidelines for manufacturing and service industry quality and can be applied to many kinds of organizations. ISO 9001 is characterized by a process-based approach, hence establishing common processes to any activity or organization, product development, or service delivery (e.g., documentation control, equipment maintenance, traceability, or staff training).
When customers need international recognition of their results or the laboratory wishes to incorporate users with international requirements, corresponding laboratory accreditation for the required tests is the best option, since it allows establishing the validity of their tests. If customers must ensure the sample traceability from the collection to result delivery, the easiest and cheapest option of quality management system is ISO 9001. At the local level, the ISO 9001 certification may be enough to provide confidence quality in the products or services offered, to be able to differentiate themselves from the competition and gain market share and public tenders, among other objectives. Alternatively, laboratory mission, vision, and policy can include issues related with market positioning, so that specific objectives should be defined regarding to certification and accreditation in each case. They allow the evaluation of the analytical performance for every variable involved (staff, equipment, reagents, and method) in comparison with the expected results. Similarly, EQA schemes are an educational tool to evaluate the competence of the laboratory in relation with specific variables. In addition to internal quality control (IQC), EQA is complementary in the quality management system. EQA programs allow comparing the laboratories’ results and informing on global variation with the objective of working toward the harmonization. The World Health Organization has an available manual for organizing a national EQA program for health laboratories and other testing sites, providing guidance on the international standards ISO 17043:2010 Conformity assessment—general requirements for proficiency testing and ISO 13528:2015 Statistical methods for use in proficiency testing by interlaboratory comparison. The EQA participation process is summarized in Figure 2. Samples prepared by the EQA provider are sent to the laboratories for their analysis.
Statistical: an acceptable result is defined by its similarity with others derived from the same method. The disadvantage of this kind of acceptance limit is that it varies between methods. Clinical: based on medical decisions. In case of nonregulatory EQA participation, the laboratories should decide the proper limits for the proposed objective. The optimal EQA participation frequency has not already established, but targeted high-quality schemes with a proper number of samples are preferred instead of many schemes with a risky participation rate. The use of validated commutable samples and the assigned value definition based on a reference measurement procedure or by comparison with a certified reference material makes an EQA program prominent. An EQA sample is commutable when the result after the analysis by a variety of methods is equivalent to the result obtained from patient samples with the same amount of analytes. However, commutability is not always possible since enough volume of EQA samples with relevant concentrations must be prepared in homogeneous and stable conditions. Additionally, to use biological samples as reference material is necessary in their certification precise information about their characteristics (processing, purity, characterization, “fitness for purpose”, homogeneity, stability) and about their original clinical, biological, and pathological diagnosis. If commutable samples are not available, it is not possible to evaluate method accuracy. In this sense, laboratories are evaluated and classified by groups of participants with the same method and expected matrix-related bias (peer groups) because comparison to the same assigned value is impracticable. The assigned value is the group mean or median after outliers’ removal or by using robust statistical tools and deviation is calculated.
Another disadvantage is that peer group evaluation is made impossible to identify a poor performance result when all reagents from the participants are affected. In spite of previous limitations, this type of EQA allows to measure the quality of the results with respect to the method and the other laboratories in the same group. Ideally, and with the previously commented objective of laboratories’ result harmonization, international EQA programs are recommended. In a second phase, these laboratories would participate in smaller national or regional programs with an optimal design as reference laboratories. In the frame of this initiative, results from EQA should be reviewed by a professional international advisory board to inquire the root causes for global deviations. A particular case of testing is the point-of-care (POC) technologies, which has the very prominent advantage of increasing the populations’ access to diagnoses through introduction of a decentralized model. To deal with this situation, connected devices to a central database for POC technologies have been developed to establish an efficient and on time EQA workflow. To be clear, EQA participation does not improve directly the quality, but it identifies and monitors poor performance issues. The laboratory must choose an EQA organizer in function of the EQA designs offered and the own quality assurance or supporting needs of the laboratory. This selective process should be justified and documented. The choice is easier when proficiency testing with a regulatory purpose is imposed. EQA providers with professional committees and accredited laboratories are preferable. With this objective, EQA provider must inform about EQA programs’ designs and especially about analytical performance specifications used in each case. This information will allow the comparison between different EQA programs, as harmonization of analytical performance specifications for the same analyte has not been achieved yet.
A proactive attitude by the laboratory is also necessary, even mandatory in the case of accreditation, for proper and timely EQA report revision. Reports from EQA providers are often used as a quality follow-up tool by auditors. In addition, reports may contain the number and origin of the participants and their distribution of results to allow comparison between them and even the laboratory’s performance history. Summary reports at the end of each scheme or program with global and anonymized information about analytical performance variation for different analyses. Periodic reports can be published as well to highlight the most significant results found. A very important supporting element for the evaluation in the reports, and required by international standards, is graphical representations. Graphs are also powerful tools to show combined information from a variety of analysis with different samples, time points, or other relevant variables. Quality improvement of the laboratory after EQA participation will be only possible if changes in the deviated processes are developed. As part of their educational, training, and helping responsibilities, EQA providers should support and collaborate with the laboratory in this phase. Proposed corrective actions must be documented and include the steps taken to find the cause of the deviation and to solve its consequences. It is a public instrument, only valid for quantitative analysis, which proposes actions to be initiated in the format of corrective and preventive action (CAPA) documentation or root cause analysis (RCA) after deviation identification by EQA. Four points are considered in the flowchart and associated comments: the potential cause of deviation, the corresponding responsibility for this cause, a brief, and, finally, a detailed explanation about the proposed actions.
The previous points are classified according to the consecutive steps in the EQA participation process: Transcription errors: the most frequent cause. Pre-survey issues: unrelated to the laboratory. Unfortunately, sample reanalysis is necessary. Sample receipt or handling: derived from incorrect address information, misunderstanding of EQA provider instructions, bad integrity of the EQA sample, or lack of records. Test performance: new or old causes that made necessary to identify who, when, and how, to look at the internal quality control data (IQC), and to look for systematic deviations from different participations over time. Data handling by EQA provider: these errors are due to the statistical procedure, their identification by the laboratory being difficult. Report and interpretation. Although EQA has been usually applied to analytical performance, the EQA process should meet in the same manner the pre-analytical phases. Few resources are necessary to organize and participate, and relevant recommendations may be included. Type II: sample analysis with simulated problems. However, only limited pre-analytical deviations can be generated. Type III: registration of incidences. This kind of pre-analytical EQA schemes offers the opportunity to EQA providers for harmonization of quality indicators (QIs). Pre-analytical EQA schemes are more difficult to standardize, but it is worth progressing in this sense because these phases are more prone to errors. The design of such programs should be developed carefully to obtain useful information. Biobanks are singular laboratories that provide samples for research. Therefore, EQA process provides an opportunity for harmonization in the biobanking field as well. Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution 3.0 License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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clinical laboratory technical procedures manual
; The New Poor Man's (Person's) Guide to the Regulations, Laessig and Ehrmeyer. Software installation required may be required Printed Spiral or Perfect (glued along the spine) Bound - depending on the standard Please contact our Customer Service team. If you would like to add additional copies of this product please adjust the quantity in the cart.Please contact our Customer Service team.Please change the currency. Please contact our Customer Service Team. Some features of WorldCat will not be available.By continuing to use the site, you are agreeing to OCLC’s placement of cookies on your device. Find out more here. Numerous and frequently-updated resource results are available from this WorldCat.org search. OCLC’s WebJunction has pulled together information and resources to assist library staff as they consider how to handle coronavirus issues in their communities.However, formatting rules can vary widely between applications and fields of interest or study. The specific requirements or preferences of your reviewing publisher, classroom teacher, institution or organization should be applied. Please enter recipient e-mail address(es). Please re-enter recipient e-mail address(es). Please enter your name. Please enter the subject. Please enter the message. Clinical laboratory technical procedure manuals-Third ed.; approved guideline (1996) -- H5-A3. Procedures for the handling and transport of diagnostic specimens and etiologic agents-Third ed.; approved standard (1994) -- H18-A. Procedures for the handling and processing of blood specimens; approved guideline (1990). Please select Ok if you would like to proceed with this request anyway. Preparation and testing of reagent water in the clinical laboratory-Third ed.; approved guideline (1997) -- C24-A. Internal quality control testing: principles and definitions; approved guideline (1991) -- C28-A. How to define and determine reference intervals in the clinical laboratory; approved guideline (1995) -- GP2-A3.
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Please try again.Please try again.Please try again. A must companion for laboratory manangers, medical directors and lead technologists. 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. 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. 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.
PUBLICATIONS An document is published as a standard, guideline, or committee report. Standard A document developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. A standard may, in addition, contain discretionary elements, which are clearly identified. Guideline A document developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the user to fit specific needs. Report A document that has not been subjected to consensus review and is released by the Board of Directors. CONSENSUS PROCESS The voluntary consensus process is a protocol establishing formal criteria for: the authorization of a project the development and open review of documents the revision of documents in response to comments by users the acceptance of a document as a consensus standard or guideline. Most documents are subject to two levels of consensus proposed and approved. Depending on the need for field evaluation or data collection, documents may also be made available for review at an intermediate (i.e., tentative ) consensus level. Proposed An consensus document undergoes the first stage of review by the healthcare community as a proposed standard or guideline. The document should receive a wide and thorough technical review, including an overall review of its scope, approach, and utility, and a lineby-line review of its technical and editorial content. Tentative A tentative standard or guideline is made available for review and comment only when a recommended method has a well-defined need for a field evaluation or when a recommended protocol requires that specific data be collected. It should be reviewed to ensure its utility. Approved An approved standard or guideline has achieved consensus within the healthcare community.
Clinical laboratory technical procedure manuals-Third ed.; approved guideline (1996) -- H5-A3.All rights reserved. You can easily create a free account. Some features of WorldCat will not be available.By continuing to use the site, you are agreeing to OCLC’s placement of cookies on your device. Find out more here. Numerous and frequently-updated resource results are available from this WorldCat.org search. OCLC’s WebJunction has pulled together information and resources to assist library staff as they consider how to handle coronavirus issues in their communities.However, formatting rules can vary widely between applications and fields of interest or study. The specific requirements or preferences of your reviewing publisher, classroom teacher, institution or organization should be applied. Please enter recipient e-mail address(es). Please re-enter recipient e-mail address(es). Please enter your name. Please enter the subject. Please enter the message. Author: Gerald A Hoeltge; National Committee for Clinical Laboratory StandardsPlease select Ok if you would like to proceed with this request anyway. All rights reserved. You can easily create a free account. A guideline for global application developed through the consensus process. 2. Serving the World s Medical Science Community Through Voluntary Consensus is an international, interdisciplinary, nonprofit, standards-developing, and educational organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. It is recognized worldwide for the application of its unique consensus process in the development of standards and guidelines for patient testing and related healthcare issues.In addition to developing and promoting the use of voluntary consensus standards and guidelines, provides an open and unbiased forum to address critical issues affecting the quality of patient testing and health care.
Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition.Users should expect revised editions of any given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of documents. Current editions are listed in the Catalog, which is distributed to member organizations, and to nonmembers on request. If your organization is not a member and would like to become one, and to request a copy of the Catalog, contact the Executive Offices. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without written permission from, except as stated below.Reproduced with permission, from publication GP2-A4 Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition (ISBN ). Copies of the current edition may be obtained from, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania, USA. Permission to reproduce or otherwise use the text of this document to an extent that exceeds the exemptions granted here or under the Copyright Law must be obtained from by written request. To request such permission, address inquiries to the Executive Director,, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania, USA. Copyright The National Committee for Clinical Laboratory Standards. Suggested Citation (. Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition.Hartford, Connecticut Specialty Laboratories Santa Monica, California Statistical Services Traverse City, Michigan Litton Pathology Associates Blue Springs, Missouri v 8 Number 5 Advisors (Continued) Eleanor M. Travers, M.D. Department of Veterans Affairs Medical Ctr. Sutter Health Mayo Clinic Mayo Clinic UroCor, Inc.CLMA College of American Pathologists GlaxoSmithKline Nippon Becton Dickinson Co., Ltd.
It should be reviewed to assess the utility of the final document, to ensure attainment of consensus (i.e., that comments on earlier versions have been satisfactorily addressed), and to identify the need for additional consensus documents.Provisions in standards and guidelines may be more or less stringent than applicable regulations. Consequently, conformance to this voluntary consensus document does not relieve the user of responsibility for compliance with applicable regulations. COMMENTS The comments of users are essential to the consensus process. Anyone may submit a comment, and all comments are addressed, according to the consensus process, by the committee that wrote the document. All comments, including those that result in a change to the document when published at the next consensus level and those that do not result in a change, are responded to by the committee in an appendix to the document. Readers are strongly encouraged to comment in any form and at any time on any document. Address comments to the Executive Offices, 940 West Valley Road, Suite 1400, Wayne, PA 19087, USA. VOLUNTEER PARTICIPATION Healthcare professionals in all specialties are urged to volunteer for participation in projects. Please contact the Executive Offices for additional information on committee participation. 3 Volume 22 GP2-A4 Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition Abstract Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition ( document GP2-A4) presents the important components of writing and managing procedures for the clinical laboratory. This guideline describes common and specific sections that should be included when developing laboratory procedures. Several examples of procedures for preanalytic, analytic, and postanalytic laboratory activities are provided in the form of appendixes; such appendixes are simply illustrative, and not prescriptive.
Sample Document Change Request Form Summary of Comments and Working Group Responses Summary of Delegate Comments and Working Group Responses Related Publications xiv 17 Volume 22 GP2-A4 Foreword Previous editions of document GP2 have focused on essential elements to include in laboratory analytic test procedures. This edition of GP2 has been expanded to provide: guidelines for writing procedures for the preanalytic, analytic, and postanalytic activities that represent the laboratory s path of workflow; guidelines for writing procedures specifically for multitest automated analyzers; an introduction to the management and control of laboratory procedure documents after they are approved for use; and the use of process flowcharts to depict the linkages between laboratory procedures. The information and examples provided in this edition are also consistent with the guidance described in document GP26 A Quality System Model for Health Care. This edition of GP2 is applicable to any size laboratory, wherever it may be in the transition of its quality program from traditional quality control and quality assurance practices to the concepts of quality systems management. Key Words Document management, electronic procedures, laboratory procedure, procedure manual, technical procedures xv 18 Number 5 xvi 19 Volume 22 GP2-A4 1 Introduction Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition The laboratory should provide carefully documented instructions in the form of procedures for all activities that support the performance of analytic testing. These instructions provide essential information for both new and experienced employees on how to perform all their job tasks including nontesting tasks such as collecting blood specimens and using the laboratory s computer system. Written procedures should encompass an entire task from start to finish.
Therefore, it makes sense to write separate instructions for tasks that are performed at different times by different people. GP2-A4 is intended to be used by the following persons: administrative and technical personnel who write laboratory procedures; manufacturers; and educators. 2 Scope This publication describes how to: identify laboratory procedures using the laboratory s operational path of workflow; and write procedures for preanalytic, analytic, and postanalytic laboratory activities. In addition, this edition of GP2 provides useful information about preparing, approving, maintaining, changing, and reviewing laboratory documents. 3 Definitions a Document, n Any recorded item of a factual or informative nature, either paper or electronic. Form, n A paper or electronic document on which the results from the performance of a procedure or other information are captured. Policy, n A written statement of overall intentions and directions defined by those in the organization and endorsed by management. Procedure, n A specified way to perform an activity; NOTE: For a quality system, a procedure is a set of instructions that describe the stepwise actions to be taken to complete activities identified in processes. Process, n Set of interrelated or interacting activities that transform inputs into outputs; NOTE: It may be documented as flowcharts or tables that describe the path of operational workflow in the laboratory.For complete definitions and detailed source information, please refer to the most current edition of that document. An global consensus guideline. All rights reserved. 1 20 Number 5 4 Path of Workflow Laboratory work is a sequence of key processes in which the laboratory uses resources, such as people, machines, methods, and materials to transform orders for laboratory tests into results and reports for patient management. Key processes for the laboratory are referred to as the path of workflow, which is shown in Figure 1.
Ortho-Clinical Diagnostics, Inc. Roche Diagnostics, Inc. Professional Members AISAR-Associazione Italiana per lo Studio degli American Academy of Family Physicians American Association for Clinical Chemistry American Association for Respiratory Care American Chemical Society American Medical Technologists American Public Health Association American Society for Clinical Laboratory Science American Society of Hematology American Society for Microbiology American Type Culture Collection, Inc.Agilent Technologies, Inc. BD BD Biosciences San Jose, CA BD Consumer Products BD Diagnostic Systems BD Italia S.P.A. BD VACUTAINER Systems Beckman Coulter, Inc. Beckman Coulter, Inc. Bio-Rad Laboratories, Inc. - France Biotest AG Blaine Healthcare Associates, Inc. Bristol-Myers Squibb Company Canadian External Quality Assessment Laboratory Capital Management Consulting, Inc. Carl Schaper Checkpoint Development Inc. Chiron Corporation ChromaVision Medical Systems, Inc. Chronolab Ag Clinical Design Group Inc. Clinical Laboratory Improvement Consultants Cognigen Community Medical Center (NJ) Control Lab (Brazil) Copan Diagnostics Inc. Cosmetic Ingredient Review Cubist Pharmaceuticals Dade Behring Inc. - Deerfield, IL Dade Behring Inc. - Glasgow, DE Dade Behring Inc. - Marburg, Germany Dade Behring Inc. - Sacramento, CA Dade Behring Inc. - San Jose, CA Diagnostic Products Corporation Eiken Chemical Company, Ltd. Electa Lab s.r.l. Enterprise Analysis Corporation Essential Therapeutics, Inc. EXPERTech Associates, Inc. viii F. Hoffman-La Roche AG Fort Dodge Animal Health General Hospital Vienna (Austria) Gen-Probe GlaxoSmithKline Greiner Bio-One Inc. Helena Laboratories Home Diagnostics, Inc. Immunicon Corporation Instrumentation Laboratory International Technidyne Corporation IntraBiotics Pharmaceuticals, Inc. Laboratory Specialists, Inc.Novartis Pharmaceuticals Corporation Ortho-Clinical Diagnostics, Inc. (Raritan, NJ) Ortho-Clinical Diagnostics, Inc. (Rochester, NY) Oxoid Inc.
Paratek Pharmaceuticals Pfizer Inc Pharmacia Corporation Powers Consulting Services Premier Inc. The Product Development Group QSE Consulting Quintiles, Inc. Radiometer America, Inc. Roche Diagnostics GmbH Roche Diagnostics, Inc. Roche Laboratories (Div. Second Opinion Showa Yakuhin Kako Company, Ltd. Streck Laboratories, Inc. SurroMed, Inc. Sysmex Corporation (Japan) Sysmex Corporation (Long Grove, IL) The Clinical Microbiology Institute The Toledo Hospital (OH) Trek Diagnostic Systems, Inc. Versicor, Inc. Vetoquinol S.A. Visible Genetics, Inc. Vysis, Inc. Wallac Oy Wyeth-Ayerst Xyletech Systems, Inc. John General Hospital (Fort St. Alexius Medical Center (ND) St. Anthony Hospital (CO) St. Anthony s Hospital (FL) St. Barnabas Medical Center (NJ) St-Eustache Hospital (Quebec, Canada) St. Francis Medical Ctr. (CA) St. John Hospital and Medical Center (MI) St. John Regional Hospital (St. John, NB, Canada) St. Joseph Hospital (NE) St. Joseph s Hospital Marshfield Clinic (WI) St. Joseph Mercy Hospital (MI) St. Luke s Regional Medical Center (IA) St. Mary Medical Center (IN) St. Mary of the Plains Hospital (TX) St. Paul s Hospital (Vancouver, BC, Montreal) St. Vincent Medical Center (CA) Ste.Inpatient Blood Specimen Collection Process Flowchart Attachment J2. Inpatient Blood Specimen Collection Process Table Attachment J3. Analyzer Testing Process Flowchart Attachment J4. Analyzer Testing Process Table Attachment J5. Bacteriology Culture Process Flowchart Attachment J6. Bacteriology Culture Process Table Attachment J7. Transfusion Medicine Prenatal Testing Process Flowchart Attachment J8. Transfusion Medicine Prenatal Testing Process Table Attachment J9. Surgical Pathology Specimen Process Flowchart Attachment J10. Surgical Pathology Specimen Process Table Appendix K1. Document Creation, Review, and Approval Process Flowchart Appendix K2. Document Creation, Review, and Approval Process Table Appendix L.
Preanalytic Processes Analytic Processes Postanalytic Processes Figure 1. Laboratory Path of Workflow. Adapted from document GP26 A Quality System Model for Health Care. 4.1 Preanalytic Processes Preanalytic key processes in the path of workflow for the anatomic and clinical laboratory specialties include all activities from the time the laboratory tests are ordered through the time that the specimens are processed and delivered to the laboratory testing location or transported to reference laboratories. For anatomic pathologists and cytotechnologists, preanalytic activities extend from the time the tissue is removed or collected to the point where the slides are prepared and ready for diagnostic assessment and interpretation. Adapted from document GP26 A Quality System Model for Health Care. 4.2 Analytic Processes Analytic key processes for the clinical laboratory specialties include the activities of performing the test, verifying the validity of the test results, interpreting the findings, and recording the findings. In the anatomic pathology specialties, analytic key processes include the diagnostic assessment of the slides, peer review, and recording the findings. Traditionally, laboratories have been functionally and often physically divided into the specific clinical disciplines of chemistry, hematology, microbiology, and transfusion service for specialized testing methods and instruments. More recently, many laboratories have segregated along manual and automated testing methods. Each laboratory or clinical discipline however it is organized should identify its automated and manual testing processes. Analytic key processes for the laboratory s path of workflow are shown in Figure 3. Testing Results Review, Recording and Follow-Up Interpretation Figure 3. Laboratory Analytic Key Processes. Adapted from document GP26 A Quality System Model for Health Care. 2 An global consensus guideline. All rights reserved. 21 Volume 22 GP2-A4 4.
3 Postanalytic Processes Postanalytic key processes in the path of workflow include activities related to reporting results and archiving results and specimen material. Postanalytic processes are shown in Figure 4. Result Reporting and Archiving Specimen Retention Figure 4. Laboratory Postanalytic Key Processes. Adapted from document GP26 A Quality System Model for Health Care. 5 Laboratory Procedure Contents Common Elements The laboratory should have procedures that describe preanalytic, analytic, and postanalytic activities in the laboratory operational workflow. The procedure document describes the series of steps to be followed by one individual to complete a specific task. Written procedures should specifically explain how to perform each activity in the laboratory s preanalytic, analytic, and postanalytic work processes. A set of common elements should be included in each type of procedure. At a minimum, laboratory procedures should include: Title; Purpose or principle; Procedure instructions; References; Author; and Approval signatures. Appendix A provides a tabular view of what should be included in a procedure document. Additional elements that are specific to analytic vs.Appendixes B through F are examples of laboratory procedures. For additional information on the distinction between processes and procedures, see Appendix J. 5.1 Title All procedures should have a title that clearly states the intent of the document. The title should be concise and descriptive, for example: Blood Specimen Collection Process; Performing Glucose Testing on Instrument X; Waterbath Temperature Monitoring Procedure; and Preparing Gram Stain Working Solutions. An global consensus guideline. All rights reserved. 3 22 Number Purpose or Principle The document should open with a section that simply states its purpose. For example, the Purpose section of a procedure could be stated as, This procedure provides instructions for collecting fingerstick specimens for glucose analysis.
The words, This procedure provides instructions for can be standardized in the template for all procedure documents. Information regarding the theory, clinical implications of the test or test methodology, or historical background may also be included at the beginning of the document, thereby providing an educational, clinical, and scientific framework for the reader and user. 5.3 Procedure Instructions The primary focus of a procedure is to provide instructions for how to do a particular task in a stepwise fashion for example, the steps involved in verifying patient identification at the time of blood specimen collection. 5.4 References Procedures should include the references that were used as the source of the information, when applicable. The references may originate from any of the following: manufacturer s product literature; text books; published standards and guidelines; laboratory policy manuals; laboratory information technology manuals; unpublished information obtained from experts in the field; and applicable regulations. References should be listed in a standard medical format. 5.5 Author The author(s) of the document should be noted. The laboratory has the option of including author information directly on the document, or on another document that can be referenced to the specific document. If the laboratory chooses to use a separate document to record the author, a mechanism should be in place that enables the referencing of the author back to the appropriate specific document. 5.6 Approval Signatures There should be evidence that the procedure has been approved by the appropriate individual(s). (Note: Document approval by an appropriate individual is a requirement of regulatory and accrediting agencies in some countries.) The laboratory has the option of including signature approval information directly on the document, or on another document that can be referenced to the specific document.
If the laboratory chooses to use a separate document to record signature approvals, a mechanism should be in place that 4 An global consensus guideline. All rights reserved. 23 Volume 22 GP2-A4 enables the referencing of the approval signature back to the specific document. Guidance for this approach to approval signatures is provided in Section Procedure Documents Specific for the Path of Workflow 6.1 Preanalytic Procedures Preanalytic procedures provide the instructions for all activities of laboratory workflow that take place before sample analysis. The laboratory should have separate written procedures for preanalytic activities, because they may be performed by nonlaboratory as well as laboratory persons at different times in the preanalytic work flow. Preanalytic procedures include those for: test ordering instructions for entering laboratory test orders into a computer system or completing paper requisitions including verification of clinical orders; specimen collection instructions for identifying patients, collecting blood and nonblood specimens, and labeling collected specimens; specimen transport instructions for transporting specimens to the laboratory, such as through the pneumatic tube system; and specimen processing instructions for receiving and accessioning specimens in the laboratory, any storage or processing before delivery at the testing section, and any preparations for preparing specimens to be transported to other laboratories for testing (e.g., reference laboratories). In addition to the elements common to all documents described in Section 5, preanalytic procedures should contain the following types of information; however, this information should be included only where it is needed to perform that procedure.
Patient preparation in procedures for specimen collection; Specimen collection in procedures for collection techniques for blood and nonblood specimens; Required equipment and forms in all preanalytic procedures where equipment and forms are used; Safety general or specific instructions as described below; Specimen handling requirements instructions for handling collected specimens during transport to the laboratory receiving area; Specimen storage requirements instructions for where and how to store specimens before testing; and Problems or pitfalls Patient Preparation Where applicable, preanalytic specimen collection procedures should include information about patient preparation such as instructions for: An global consensus guideline. For example: Test requisitions and labels; Specimen collection devices and materials (e.g., blood collection tubes, media, swabs); Specimen containers; and Instruments (tourniquets, hemostats, scissors, etc.) Safety Preanalytic procedures should include safety instructions for the collection and handling of biohazardous specimens. The instructions should be written for the intended readership for example, those who handle the specimen such as nursing, transport, or laboratory personnel. If no special precautions are required, preanalytic procedures may refer the user to the safety policy manual for general safety requirements. A Special Safety Precautions section should be included in preanalytic procedures when additional safety requirements beyond the basic handling of biologic and other hazardous materials are necessary (see documents M29 Protection of Laboratory Workers from Occupationally Acquired Infections and GP17 Clinical Laboratory Safety.) Specimen Handling Requirements Where applicable, preanalytic procedures should include information about specimen handling requirements. This information includes: special transport requirements (e.g., on ice, within a certain time, in appropriate containers, etc.
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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.
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clinical laboratory reference manual
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clinical laboratory reference manual
We do not discriminate against, exclude or treat people differently because of race, color, national origin, age, disability, sex, sexual orientation, gender or gender identity. Please see our Fairview Patients’ Bill of Rights or HealthEast Patients' Bill of Rights. If you speak another language, assistance services are available to you free of charge. Call 1-612-273-3780. Persons with hearing or speech disabilities may contact us via their preferred Telecommunication Relay Service. From developing new therapies that treat and prevent disease to helping people in need, we are committed to improving health and well-being around the world. The Merck Manual was first published in 1899 as a service to the community. The legacy of this great resource continues as the Merck Manual in the US and Canada and the MSD Manual outside of North America. Learn more about our commitment to Global Medical Knowledge. Click on the tabs above to explore the many resources available. Information about The University of Texas at El Paso College of Health Sciences can be found here. This guide will provide you with both print and online resources to help you begin your research either at or via the University Library. The Manual was first published as the Merck Manual in 1899 as a service to the community. The legacy of this great resource continues as the MSD Manual outside of North America. The site is produced by AACC, a not-for-profit organization; proceeds from health-related advertising help support the website's mission. Please ensure when discussing testing options with your patients, to be mindful of the MBS criteria and possible out-of-pocket fees that may be charged. Up-to-date MBS criteria can be sourced on-line via mbsonline. Click to login or enroll. Visit our Help Center Click to login or enroll. Visit our Help Center This Specimen Collection Manual is a professional service that gives our teams the information they need to ensure your tests are collected correctly.
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Features of MyAccess include: Remote Access Favorites Save figures into PowerPoint Download tables as PDFs Go to My Dashboard Close MHE Privacy Center. We are proud to offer an extensive menu of clinical tests and services through our four CLIA-certified, CAP-accredited laboratories at Moffitt-Long Hospital, Mission Bay Hospitals, Mt. Zion, and China Basin.You can search for tests as well as find information about laboratory operations and policies, our accreditation and licensing, and other helpful resources. Each test entry contains information about the testing site, method, sample requirements, availability, normal ranges, critical values, as well as additional information on patient preparation, collecting samples, test interpretation, and utilization guidance. Federal CLIA regulations require that we only refer samples for testing to other CLIA (or equivalent) certified laboratories. If the test is available at one of our approved, CLIA certified reference laboratories, it may be ordered in APeX as a Miscellaneous Outside Lab Test (MOLT). When ordering a MOLT, please include the exact name of the test and the name of the laboratory to which it will be sent. Tests on laboratory animals for research purposes, which are charged against research funds, can be performed only after prior arrangement with the Medical Director of the respective section. Further, per Medical Center policy, the UCSF Clinical Laboratories will not process, package or ship research samples to external research or commercial laboratories. If problems arise related to laboratory testing, please contact a Laboratory Medicine Resident, one of our Medical Directors or an appropriate member of our staff. HealthEast Medical Laboratory offers patient instruction sheets for collecting urine, stool, semen, sputum and more. We comply with applicable Federal civil rights laws and Minnesota laws.
His first-hand experience in the laboratory led him to create eight printed editions of Clinical Laboratory Diagnostics: Use and Assessment of Clinical Laboratory Results, an interpretative guide to tests and diagnostic techniques in laboratory medicine. Since releasing the first edition in 1978, more than 230,000 copies have been published. After developing the “go-to” reference guide for nearly every clinical chemistry laboratory topic, Professor Dr. Thomas sought the support of Siemens Healthcare in developing the latest version. With our customers in mind, we have supported the development and publication of an easy-to-use, downloadable app. And, because every lab should have access to educational material that will support enhanced patient outcomes, the app will be available free of charge. Available for iOS iPads and Android tablets, the app includes information on more than 1000 biomarkers, and spans topics from toxic metals to tumor markers. Each laboratory test is reviewed by: Indication Method of Determination Specimen Reference Interval Clinical Significance Comments and Problems Biochemistry and Physiology References The searchable app also contains valuable insight on quality assurance, reference materials, and standardization of laboratory medicine methodology guidelines, among others. Click here to download the Android app. Click here to download the iOS app. Feedback Thank you. Would you like to provide detailed feedback. Last updated June 28, 2019. Hematology reference ranges. Glengarry Memorial Hospital. Effective date June 25, 2019. Reticulocyte count and reticulocyte hemoglobin content. Retrieved April 27, 2020, from. Hematology reference ranges. Effective date June 25, 2019. Hematology reference ranges. Effective date June 25, 2019. Last updated June 28, 2019. Last updated June 28, 2019. Last updated June 28, 2019. Retrieved April 15, 2020, from Hematology reference ranges. Effective date June 25, 2019. Last updated June 28, 2019.
This reduces the chance of an incorrect test result. It serves communities in 28 states. The organization offers acute and ambulatory care, an insurance company with a dental plan, and post-acute and academic business lines. Driven by its Mission to improve your health and well-being, ProMedica has been nationally recognized for its advocacy programs and efforts to address social determinants of health. For more information about ProMedica, please visit About Us. We also use cookies to measure the effectiveness of public health campaigns and understand how people use the website. Call us on 1850 24 1850 or 01 240 8720. In addition it operates smaller laboratories at Christchurch Women?s, Burwood and Ashburton Hospitals. ForThis document should be used as a guide to individual testing on the basis of clinical findings and not as a complete. Medical Directors of any specialty may be called directly (see “Staff Contacts”) or contacted through the Clinical Laboratory at 720-848-4401. All cytology, surgical, and other anatomical specimens, and inquiry regarding these are the responsibility of the University of Colorado Denver Department of Pathology. Please go to UCD Department of Pathology and click “Our Services” for specimen submission guidelines. If you prefer, or if the laboratory has not addressed your concerns, contact: College of American Pathologists (CAP) Call 720-848-7029. The name of the laboratory actually performing the examination will be indicated on the laboratory report form. It has not been cleared or approved by the U.S. Food and Drug Administration. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research. By continuing to use this site you are giving us your consent. Learn how cookies are used on our site. Accept terms.
Physicians rely on the availability of suitable and reliable reference intervals to accurately interpret laboratory test results with data collected during medical history and physical examination. However, critical gaps currently exist in accurate and up-to-date reference intervals (normal values) for accurate interpretation of laboratory tests performed in children and adolescents. These gaps in the available paediatric laboratory reference intervals have the clear potential of contributing to erroneous diagnosis or misdiagnosis of many diseases of childhood and adolescence. Most of the available reference intervals for laboratory tests were determined over two decades ago on older instruments and technologies, and are no longer relevant considering the current testing technology used by clinical laboratories. It is thus critical and of utmost urgency that a more acceptable and comprehensive database be established. There are however many challenges when attempting to establish paediatric reference intervals. Paediatric specimen collection is a major concern for health care providers as it is frequently difficult to obtain sufficient volumes of blood or urine from paediatric patients. Common reference intervals have not been widely implemented due to lack of harmonisation of methods and differences in patient populations. Consequently, clinical laboratory accreditation organisations and licensing agencies require that each laboratory verify or establish reference intervals for each method. To provide such reference intervals requires selection criteria for suitable reference individuals, defined conditions for specimen collection and analysis, method selection to determine reference limits and validation of the reference interval.
Last updated June 28, 2019. Measurement of ACTH, CRH, and other hypothalamic and pituitary peptides. Retrieved April 14, 2020, from. Last updated June 28, 2019. Retrieved April 15, 2020, from. Last updated June 28, 2019. Last updated June 28, 2019. Retrieved April 14, 2020, from. Last updated June 28, 2019. Last updated June 28, 2019. Authors can decide if they want to include the LDL analysis table (see below). Last updated June 28, 2019. Last updated June 28, 2019. In Merck manual professional edition. Retrieved April 14, 2020, from. Last updated June 28, 2019. Last updated June 28, 2019. Last updated June 28, 2019. In Merck manual professional edition. Retrieved April 14, 2020, from In Merck manual professional edition. Retrieved April 14, 2020, from You may unsubscribe via the link found at the bottom of every email. (See our Email Privacy Policy for details.) Emails are serviced by Constant Contact. To find out more about our use of cookies and how you can change your cookie settings, please review our Terms of Use: I accept cookies I refuse cookies. Call 404-778-7777 7:30 a.m. to 6 p.m. EST (M-F)EML performs nearly 4 million tests per year and employs over 400 laboratory professionals. In addition, EML has over 25 faculty members who actively participate in the clinical, research, and education missions of Emory Healthcare. We look forward to hearing from you. Terna was an athlete all his life, and from a young age, he had a dream to play college football. This Web site is provided solely for personal and private use of individuals accessing this information, and no part of it may be used for any other purpose. Requests to do so should be addressed to the Editor. Abstract Screening, diagnosis and monitoring of paediatric diseases relies on the measurement of a spectrum of disease biomarkers in clinical laboratories to guide important clinical decisions.
Drugs-of-abuse testing in children is another area in which data are very limited but could have important implications for growth, development and overall patient care. Finally, metabolism differs in children and will affect therapeutic drug monitoring and therapy. For instance, different antibiotics are indicated for children and not adults. Many of the problems associated with establishing good reference intervals for adults also exist for the paediatric population. Current paediatric reference intervals have been derived predominantly from samples collected on hospitalised infants and children of the Caucasian population and may not reflect levels in healthy multicultural populations. 2 Collecting samples from healthy children is difficult, particularly from premature infants, term infants and toddlers. The influences of prematurity on laboratory test results are poorly understood and have not been assessed systematically. Different rates of organ maturation occur after premature birth; however, due to concerns about blood volume depletion in premature infants, it has been difficult to study reference intervals. Recruiting children as research subjects poses ethical dilemmas and protocols with institutional review board approval and informed consent are required for reference interval studies on normal, healthy children. Alternative ways of developing reference intervals for established tests require further study and could include mathematical approaches, extrapolation and establishment of decision limits. There is also a need to include a diversity of ethnic groups into paediatric reference interval databases. Application of reference ranges specific to other ethnic groups is clinically inappropriate for many biomarkers.
Manufacturer supplied reference intervals are often not accompanied with a detailed description of how reference intervals were derived including partitioning factors, sub-class differences, sample size, age, gender, ethnicity, race, percentiles used or traceability. Different critical values and reference intervals for the same analyte exist between different laboratories and analytical platforms. In May 2008, the Hospital for Sick Children devised and mailed out a survey to collect critical values provided by paediatric hospitals across Canada. An example of the variability observed between laboratories for glucose critical values at the low end is shown in the Figure. Hypoglycaemia is the most common metabolic problem in neonates. Sustained or repetitive episodes of hypoglycaemia associated with neonatal hyperinsulinaemia, inborn errors of carbohydrate metabolism or diabetes mellitus in children has a major impact on normal brain development and function. Adequate glycaemic control in the paediatric population is also hampered by variability in analytical methodology and reference intervals for insulin (The Table provides a few examples of instrument specific reference intervals determined as part of the CALIPER pilot projects at the Hospital for Sick Children in Toronto). Despite use of a standardised calibrator across different analytical methods, a difference in paediatric age-specific reference intervals exists for insulin perhaps suggesting need for method-specific reference intervals to account for differences in antibody specificity. Inconsistency in paediatric reference intervals also extends to immunoassays for other hormones without standard reference material including oestradiol ( Table ). Sex hormones are present at substantially lower concentrations in infants and children compared to adolescents and adults.
The current review will provide a brief introduction to the current approach to establishment of reference intervals, will highlight the current gaps in data available in paediatric populations, and review a recent Canadian initiative, CALIPER (Canadian Laboratory Initiative on Paediatric Reference Intervals), to establish a comprehensive database for both traditional and emerging biomarkers of paediatric disease. Paediatric Reference Intervals: Gaps and Challenges It is well recognised that paediatricians and paediatric specialists have unique needs and requirements for the laboratory testing of their patients. Age-specific reference intervals and specimen collection issues are particular concerns in paediatric patient care and evaluation. Frequently, adult reference intervals are not appropriate for paediatric patients. To assist physicians in treating their paediatric patients, attempts have been made by many laboratories to establish age-specific reference intervals for many traditional disease biomarkers with limited success. Unfortunately, critical gaps currently exist in available paediatric reference intervals for accurate interpretation of laboratory tests (results of a recent gap analysis is discussed further below). 1 These gaps may subject infants and children unnecessarily to extra blood collection, infectious risk, stressful diagnostic procedures or inappropriate treatment. Children are not small adults. Therefore, establishing paediatric reference intervals requires a more complex approach, considering not only age, gender and ethnicity but reflecting the significant differences that exist in nutritional status, growth, development, disease frequencies, specimen collection, test performance and test interpretation. Age-specific reference intervals are important for all types of paediatric laboratory testing. Many endocrinology, chemistry, serology, coagulation and haematology markers are subject to age-specific variability.
Serology test results are influenced by the transplacental passage of maternal IgG and by immunisation responses in infants and children. Coagulation tests are optimised for anti-coagulation monitoring and not for childhood genetic diseases such as haemophilia. In haematology, the automated differential uses algorithms in children that differ from those used in adults. Currently available laboratory information systems do not permit the automatic calculation of a patient’s age related to prematurity and cannot separate reference intervals by gestational age. Unfortunately, most of the available reference intervals are incomplete covering a limited paediatric age interval that does not always cover both genders. Clearly, determining age- and gender-specific reference intervals is crucial for screening, diagnosis and monitoring of many paediatric disorders. Children often acquire diseases that differ from adults and are lower in frequency. They respond to infections in a different way and often require special testing. Premature birth can result in a set of diseases due to incomplete organ system development, especially those affecting the lungs and the central nervous system. Cancer in childhood comprises a set of neoplasms for which genetic alterations are much more important than environmental factors. Metabolic disorders and genetic diseases such as cystic fibrosis and sickle cell disease are examples of diseases diagnosed during childhood. Neonatal screening programs established in some countries are becoming more widespread with test menu expansion. Reference intervals are not available for new and emerging paediatric disease biomarkers. Cut-off ranges for health and disease are challenging and data are limited or difficult to find. Consensus guidelines established for adults may not apply to children, as is the case for cholesterol and hyperlipidaemias.
International efforts to improve paediatric hormone-testing standardisation by assuring traceability to sensitive reference methods are required. These efforts will facilitate establishment of appropriate method-specific reference intervals for neonatal and pubertal developmental stages. Common reference intervals may be applied to some assays such as total calcium, which appears to be well standardised ( Table ). Finally, the clinical utility of plasma or serum creatinine measurements for the identification of renal insufficiency is hindered by the sub-optimal quality of the non-specific Jaffe method used in several routine laboratories. The challenge lies in developing method-specific reference intervals that have been aligned with high order reference standards and validation of the Modification of Diet in Renal Disease (MDRD) formula for the paediatric population. Both the IFCC and CLSI are working together towards a more standardised method for establishing reference intervals. At the 2007 AACC meeting in San Diego a session was dedicated to the issue of reference intervals. The new CLSI guidelines (version C28-A3) were unveiled to the laboratory community. The main differences between the new C28-A3 versus the C28-A2 are as follows: Decision limits as well as reference intervals should be used for certain analytes e.g. cholesterol, glycated haemoglobin and neonatal bilirubin. Validation vs establishment of reference intervals by a laboratory is acceptable. Establishment of reference intervals through multi-centre trials. Using the “robust” statistical method as well as the nonparametric method to calculate reference intervals is valid. Laboratories should make reports easier to understand with abnormal values highlighted. Laboratories should quote either the decision limit or reference intervals, not both.
Clinical Laboratory Standards Institute (CLSI) recommends a minimum of 120 individuals, the minimum sample size required to determine 90% confidence intervals for the 95th percentile reference limits (2.5th and 97.5th percentiles). 6 There are two sampling methods: direct and indirect. Direct techniques involve selection of individuals from a population using defined criteria. Participation requires informed consent and completion of a questionnaire that ensures confidentiality. Individuals are selected based on analyte-dependent criteria and health assessment. Reference individuals are most commonly partitioned by age and gender. The direct technique agrees with IFCC recommendations and is preferred; however, the challenge and cost of obtaining a representative group of reference individuals (particularly difficult for paediatric populations) may be overcome with the indirect technique. The indirect technique involves application of statistical methods to analytical values in a laboratory database without selection of reference individuals. The indirect technique may have clinical utility in select situations including paediatrics and the elderly population where collection of sufficient numbers of reference samples may be difficult. Depending on the analyte, subject preparation may include a specified diet (fasting or non-fasting), abstinence from pharmacologic agents, a prescribed drug regimen, sampling time in relation to biological rhythms, limited physical activity (rest period) or stress. Specimen collection considerations include environmental conditions during collection, specimen type, time of day, posture, sample volume, anti-coagulants, additives, collection site preparation, blood flow, equipment and phlebotomy technique. In the paediatric population, patient age is obviously a significant pre-analytical factor and specimen collection and handling may be markedly different compared to that in adults.
Phlebotomy for infants and children is technically challenging and requires special training and skill, particularly for sites such as scalp, jugular veins and umbilical artery catheters. Paediatric patients have frequent blood draws and are at risk for anaemia necessitating small specimen volumes. Liquid anticoagulant in collection tubes may potentially dilute the specimen when sample volumes are small. Skin puncture specimens (capillary blood) are more commonly obtained from children and consist of a mixture of blood from arterioles, venules, and capillaries with interstitial and intracellular fluids. The results from various analytes deviate from those obtained with arterial or venous samples. Since automated laboratory equipment frequently cannot handle small volume specimens or samples directly from paediatric-sized tubes, manual processing of paediatric samples is common in larger laboratories making it difficult to standardise specimen processing across laboratories and to maintain positive sample identification for paediatric specimens throughout all testing phases. Small paediatric samples may also preclude repeat testing to confirm abnormal results. Analytical variables required when determining reference intervals are quality control procedures and analytical performance. The analytical method should be controlled in the same way as routine patient samples including equipment and instrument preventative maintenance and function checks, reagents, calibrators, controls and calculation methods. The analytical validity of the method is critical and the method chosen for analysis must clearly state traceability, precision, minimum detection limit, reportable range, recovery, and interference characteristics. Analytical interference is encountered more commonly in neonatal patients than in adults and represents a significant technical challenge.
Specifically, high concentrations of bilirubin, lipids, and foetal haemoglobin are present in many neonatal specimens. Bilirubin absorbs light at wavelengths at which many spectrophotometric methods measure a variety of analytes and can cause spurious test results in both chemistry and haematology laboratories. Intravenous nutrition supplemented with fat emulsions can result in specimen turbidity, which interferes with both spectrophotometric and nephelometric methods based on changes in light scatter. Foetal haemoglobin, normally present in significant quantities only in newborns and infants, interferes with accurate measurement of several haemoglobin derivatives. Carboxyhaemoglobin and methaemoglobin are critical to oxygen transport in the newborn and are important parameters for the management of neonates in the intensive care unit, but large amounts of foetal haemoglobin invalidate their conventional spectrophotometric measurement. Instrumentation appropriate to the neonatal setting can eliminate these technical issues. Statistical Evaluation of Reference Values and the Approach in Paediatrics Visual inspection of a frequency distribution histogram of values helps determine whether the distribution is Gaussian (normal, symmetric) or non-Gaussian (skewed, kurtosis, bimodal, polymodal) and identifies outliers. Non-Gaussian distributions suggest that unhealthy individuals are included or the values require partitioning. Another method of outlier detection, proposed by Tukey involves the labelling of extreme values by using the middle 50% of the sample, thus reducing, or eliminating, the possible masking effect of multiple outliers on one side of the distribution. 8 Since the majority of analytes do not have normal Gaussian distributions, the non-parametric method is recommended by IFCC and CLSI with a minimum of 120 individuals required per partition. Reference limits can be easily calculated using non-parametric ascending rank order statistics.
The conventional 95th percentile reference limits are determined by calculating the rank numbers for the 2.5th and 97.5th percentiles. If laboratories cannot establish reference intervals based on the requirement of 120 reference individuals, the bootstrap or robust methods may be applied to get a good estimate of reference intervals. The bootstrap method uses a computer to provide robust percentile estimates by re-sampling from a single subset of reference values. 9 Horne and Pesce describe the robust method where more weight is given to central values of a distribution than to distant values for the calculation of reference intervals. 10 The advantage of this approach is that it is more tolerant of outliers in the reference population data, it does not require as large a sample size as the non-parametric calculation method and it does not require reference data transformation to a Gaussian distribution. Normal values can be presented as reference intervals, decision limits or statistical cut-off values. Recent studies of paediatric reference intervals in our laboratory (under the CALIPER program) have employed non-parametric statistics to establish reference intervals. Examples are provided in the Table. Results are first reviewed to detect outliers using the Dixon’s test prior to estimating reference intervals. Any specimen that is deemed to be unacceptable on the basis of aberrant results for multiple analytes is excluded. Results that are deemed to be adversely affected by haemolysis, icterus and lipaemia interferences for any analyte are also excluded. A one way ANOVA analysis is performed to determine which age groups and gender groups could be combined. When the number of samples is less than the recommended 120, the Horn-Pesce robust method is used to estimate the 95% C.I. (confidence interval) and 95% R.I. (reference interval) of distribution as upper and lower normal reference intervals.
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