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.