Quality Assurance In Medical Laboratory – When an out-of-control event occurs, laboratories must take immediate and clear actions that identify the root cause, to prevent it from happening again.
The most important function of a clinical laboratory is to provide high-quality, medically useful laboratory results to healthcare providers in a timely manner. To this end, the laboratory must design and implement an effective quality management system to ensure accurate and reproducible results reporting. The quality control (QC) program is a component of the laboratory’s overall quality management system. And a routine quality control program should be designed to evaluate the analytical performance of laboratory measurement systems to detect potential errors during the analytical phase of testing that could negatively impact patient care.
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An out-of-control event occurs when the evaluation of a quality control rule for one or more quality control measurements produces unacceptable results. A runaway event generally means that the measurement system is not operating within normal analytical performance specifications. Out-of-control conditions must be detected and investigated to avoid reporting erroneous laboratory results that could cause patient harm.
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Once an out-of-control event has been detected, the challenge now falls to the laboratory: identify the root cause of the event, take corrective actions, mitigate any potential harm to patients, and implement preventive actions. The following are detailed recommendations for the management of runaway events, based on recommendations from the Clinical and Laboratories Standards Institute (CLSI) guidelines:
The first step in responding to an analytical measurement system error is simply to identify that it has occurred. An out-of-control event is detected when quality control values exceed acceptance limits. An automated QC alert is generated to inform the laboratory of a potential problem, or the laboratory recognizes that the result did not pass the QC acceptance criteria if manual QC review is used. The detection of a runaway event is based on the definition of target quality control means and standard deviations (SD) that represent the normal performance of the measurement system. The quality control target average should be calculated using a minimum of 10 quality control measurements taken over 10 days. This approach ensures that sufficient sources of normal analytical variation, such as variation due to different vials of quality control materials, reagent wedge changes, and daily maintenance activities, are represented in the data used to establish the quality control target mean. . It is best to calculate the target QC average using several months’ worth of data because additional sources of normal variation can be incorporated, such as multiple test calibrations, reagent lot changes, and monthly maintenance activities. The SD is not a function of the quality control material, but rather a function of the performance of the analytical measurement system. Therefore, target SDs should be calculated using several months of historical QC data to incorporate multiple sources of normal variation.
QC rule evaluations can be programmed into QC data management software to automatically alert laboratories when an out-of-control event is detected. One strategy for establishing QA rule classifications is to base QA rules on the sigma metric. The sigma metric relates analytical performance to total allowable error (TEa) and its use is described in the CLSI document C24. If a test has a large sigma metric, such as six, the test has a low error rate. Tests with a low sigma metric, such as three, have a higher error rate. For testing with a low sigma metric, the use of multiple QC rules is desirable to detect small changes or deviations in QC values.
Once a runaway alarm is detected, the laboratory must ensure that all reporting of patient results for the affected test is immediately stopped. This could include taking the test or even the entire instrument out of service if necessary. If automatic verification is performed in the laboratory, automatic verification must be disabled so that the patient’s results are not automatically reported in the medical record. Laboratories performing multi-instrument testing may redirect patient samples to other measurement systems that have acceptable quality control results while the runaway event is investigated.
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The next step is to conduct an investigation to determine the root cause of the runaway event. The root cause is the actual reason for the presence of the analytical measurement system error. It is essential to determine the root cause of the runaway event, so that the problem can be directly addressed through corrective and preventive actions.
The investigation usually begins with an examination of quality control records and Levey-Jennings charts. Can obvious user errors be ruled out quickly? For example, was the wrong level of QC material tested, or the wrong QC product, or the wrong QC lot number? Was the amount of quality control material in the sample container sufficient for analysis? Has QC material been left on the bench at room temperature for too long, causing material degradation?
Once obvious errors are ruled out, the lab can perform more detailed troubleshooting steps. Are there trends or changes observed when examining the Levey-Jennings graphs? Is the runaway event related to a recent change in the measurement system, such as a recent assay calibration, new reagent lot, or maintenance activity?
Once the root cause of the runaway event is identified, specific corrective actions can be taken to address the problem. For example, if the primary cause of the runaway event was degradation of reagent stored on board the instrument, a new reagent container can be placed on the instrument. If the primary cause of the leak event was bacterial contamination of the instrument, a decontamination procedure can be performed. Patient testing may resume if quality control meets acceptance criteria after corrective action is implemented. If the quality control does not meet the acceptance criteria, the root cause has not been determined and further troubleshooting is required.
Quality Assurance (qa)/quality Control (qc) Procedures Following The…
It is not uncommon for laboratories to assume that the response to an out-of-range QC event results in corrective action. You might think “Great! The issue has been resolved and testing of patient samples can now resume and we are done dealing with the runaway event.” However, there are still some steps to take to recover from the runaway event.
After corrective action, the laboratory must evaluate the impact of the error on previously reported patient outcomes. If, for example, the root cause of the problem had been degradation of quality control material, the patient sample results would not have been affected by the error because there was no problem with the measurement system. Most measurement system problems have the potential to affect patient sample results. If you run QC every 12 hours and a runaway event is detected, the actual measurement system problem may have occurred at any time since the last acceptable QC result was obtained and the laboratory may already has reported erroneous results in the medical report. records. Therefore, previously tested patient samples should be retested and results repeated to determine whether the magnitude of the error may have caused a clinical impact, such as inappropriate patient diagnosis or therapy based on erroneous results.
Once patient samples are retested, the repeat result (obtained after corrective action) should be compared to the original reported result to determine if the magnitude of the difference between the results is large enough to negatively affect the patient care. Acceptability criteria for the difference between repeated patient samples are established by the laboratory director and may be based on the total allowable error (TEa). TEa is defined as the general limit of acceptable inaccuracy and bias for the result of a single measurement and is used to establish the maximum error that can be tolerated without negatively affecting medical decision making. This was stated at the conference of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).
Recommendations There are three different models to determine the TEa of a test. TEa can be based on clinical outcome studies and estimates of biological variation
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(see: EFLM Biological Variation Database: https://biologicalvariation.eu/) or state-of-the-art testing. Other regulatory performance specifications may also be used, such as the Clinical Laboratory Improvement Amendments (CLIA) acceptable test performance criteria.
. If the difference between the results is outside the limits of the TEa, the error is likely to have a clinically significant impact and correct reporting is required.
The next step in the recovery process is to take steps quickly to mitigate harm to the patient. Because patients may have received inappropriate clinical actions based on erroneous results, corrected reports should be issued immediately if the magnitude of the error of the original reported results exceeds the TEa. Suppliers must be informed that a correct report has been issued.
Some approaches to quickly mitigate patient harm include developing data entry templates to automatically identify patient results that require correct reporting and calling in additional staff to assist with repeat analyzes of patient samples and calls. telephone calls to suppliers.
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The last step of the recovery process is to implement preventative actions to prevent the event from occurring again. Preventive action is different from corrective action. For example, if the runaway event was due to the instability of an integrated reagent, the corrective action would be to replace the reagent with a new reagent container. The preventive action would be to change the expiration date on board the reagent so that it can be replaced.
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