c2-QUALITY CONTROL.docx

QUALITY CONTROL =============== Quality control for laboratory equipment ---------------------------------------- The terms quality control and quality assurance are not interchangeable. Quality control is a measure of precision or of how well an instrument is functioning to produce results that...

QUALITY CONTROL =============== Quality control for laboratory equipment ---------------------------------------- The terms quality control and quality assurance are not interchangeable. Quality control is a measure of precision or of how well an instrument is functioning to produce results that will be consistent if repeated over time. Quality assurance involves ensuring that a test is as accurate as possible. This includes adhering to standard operating procedures, conducting quality control testing, and ensuring that equipment receives regular maintenance according to manufacturer recommendations. Become familiar with the supplies and equipment used in the laboratory. If you have questions about the correct operation, consult the procedure manual. A thorough understanding of laboratory tools reduces errors and provides higher-quality samples. In addition to the procedure or operational manual for each piece of laboratory equipment, there is also an equipment log. This log is a means of monitoring equipment maintenance and quality control testing. Depending on the type of equipment, perform quality-control procedures daily or when opening a new lot of supplies. Also perform them under special circumstances, such as after recording multiple errors, to determine whether the equipment is operating properly. Document in ink the time and date you ran the quality control procedures along with the results of the tests in the appropriate location on the log. For electronic record keeping, enter and save the information prior to exiting the log. Clean laboratory equipment several times per day and, at a minimum, according to the facility\'s and operational guidelines. If equipment becomes visibly contaminated, clean it prior to additional use, and document it in the log as well. If a centrifuge is making unusual noises or vibrating more than it should during the processing of specimens, balancing is likely the main concern. Place tubes of the same size and volume in the centrifuge directly across from one another with the centrifuge level on a counter or solid surface. If the volume and size of tubes do not match, the centrifuge will vibrate much like a washing machine in the spin cycle when the laundry is unbalanced. This action can lead to tube breakage and improper centrifuging of specimens. After confirming that the tubes are well balanced and the centrifuge is level, check calibration. If none of these troubleshooting techniques resolve the problem, the centrifuge might require servicing. When equipment is not working well, take simple troubleshooting steps first. If the equipment is electric and is not starting, make sure that the on/off switch is in the on position and that the plug has a secure connection to a functioning outlet. This might seem like common sense, but it is still the first step to take when troubleshooting. If there is a safety mechanism on the equipment, make sure that it is engaged. If the equipment is still not functioning after conducting these troubleshooting measures, make a report for further evaluation and repair of the equipment. For equipment that is not working correctly or not working at all, make a repair report. On the report include the date, a brief description of the issue, and the steps you took to try to fix the problem. Then make sure the repair personnel receive it promptly. It is not acceptable to ignore the issue or leave the equipment for someone else to fix. It is the responsibility of everyone who works in the department to make sure that all equipment operates correctly. Some equipment requires regular maintenance, such as yearly or every 6 months. The date this maintenance must happen is written either on the item itself or in the owner\>s manual. It is important to know the equipment, manufacturer, and process before the due date of maintenance. Waiting to learn this information until the equipment is due for service can result in maintenance delays, thus impeding quality assurance. Quality control for CLIA-waived tests ------------------------------------- To ensure that all CLIA-waived test results are as accurate as possible, make sure equipment operates correctly and that the laboratory staff stores supplies properly and performs quality-control procedures routinely. For all CUA-waived tests, follow the directions for use precisely. Never reuse supplies or use them beyond their expiration date. Run external controls when opening a new package of supplies, at the beginning of a day of testing, and when several results appear drastically out of range. If a supplies log is required, document the expiration date, serial number, and number of supplies used or remaining. It is also important to document when controls are ran, along with the date, time, control results and any other information the facility requires. The proper storage of supplies and maintenance of equipment will ensure the most accurate test results possible. At the start of the day, turn on battery-operated equipment to determine battery strength. If the battery is low or depleted, recharge the device or insert new batteries to avoid delays during patient encounters. Glucometers ----------- There are multiple ways to ensure quality control when using glucometers. These include the use of external controls, matching test strip codes to the glucometer code, and reviewing expiration dates of supplies prior to use. Perform external controls when opening a new package of strips and each day you perform the tests. Run external controls when there has been a series of drastically out-of-range blood glucose readings. Use external controls at room temperature and do not use them past their expiration date. If the results are out of range, repeat the test, again checking the expiration date and ensuring room temperature and correct application. After validating the control test results, proceed with testing for patients. Never use the strips for patients if the controls are out of range. Log the time and date of test-control results and the serial number of the glucometer on the glucometer quality control or equipment log. Some facilities require the serial number of the controls, expiration date, and name or initials of the person performing the controls. Document all information legibly using a pen. For entries in an electronic log, double-check that all information is correct and save all results before closing the log. When using a coded glucometer, the code on the meter must match the code of the strips. If the code does not match, you cannot verify that the test results are accurate and must adjust the glucometer to match the code on the strips. Check this code every time you perform blood glucose testing. Check the expiration date of the strips and use the strips closest to their expiration date first. Do not use expired strips, because they will not provide an accurate reading. Store strips at room temperature and close the package after each use. Keep strips dry and safe from extreme changes in temperature, which could skew readings. Clean glucometers with an alcohol wipe after each use. Other tests ----------- For other CUA-waived tests, the quality-control procedures are very similar to those for glucometers. Ensure properly functioning equipment that is fully charged, and a review of expiration dates of supplies, including controls. Some supplies require refrigeration or room temperature, and others must be away from light. It is important to know what handling is appropriate for each test. If you have questions, refer to the facility\'s procedure manual to confirm the appropriate action. If the information is not in the procedure manual, the individual documentation for the machine most likely includes proper handling and storage instructions.