Laboratory quality control program

Maintaining internal and external quality control programs, including the use of controls, is the key element in allowing healthcare providers to deliver timely and accurate results.

Lab techs want to know patients and physicians can rely on those results to ensure the best possible health outcomes. All our non-necessary cookies are focused on performance and marketing, which include Hotjar, Click Dimensions, and Google Analytics. These allow us to analyze performance of our website as well as allow us to better understand which feature are easier to use on our website. Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies.

It is mandatory to procure user consent prior to running these cookies on your website. Quality Control Lysing is a critical step in A1c testing Diabetes is the seventh leading cause of death in the United States. In the last 20 years, the number of adults diagnosed with diabetes has more than …. In addition, the IHRM must be stable during storage—or have known storage characteristics—since it is often used over a one-year period of time. When an IHRM is selected and meets the criteria above, it is analyzed at least twenty times over several weeks.

These analyses should include different days, different analysts, and different points within the analytical run. These data points are compiled and a standard deviation is calculated. Analyses are monitored on a control chart, which graphs IHRM results versus time. Results outside the control limits indicate that the method is not performing within specifications and all work must cease until the cause of the deviation is corrected.

An out-of-control situation is defined as follows:. There are several forms of documentation needed for an LQM program. Several logbooks including standard preparation logs, calibration logs, and analysis logs must be kept by the analyst and updated regularly. Training records must be documented as noted, and maintenance records of each piece of equipment should be kept in the laboratory. In addition, Corrective Action Protocol CAP records should be used for each out-of-control situation on a control chart and each instrument issue.

This will allow the analyst to identify root causes of problems and avoid recurrences. Each individual analyst is responsible for monitoring the control charts on a daily basis. In addition, a team of analysts should oversee the monitoring of the IHRM program. The goal of this team is to continuously monitor and improve the quality of the analytical methods.

An IHRM program is an excellent way to build confidence in your analytical testing procedures and, in turn, the quality of your product.

The costs are few in comparison to the benefits of a laboratory quality management program. Access My Transcript. Change Password. Quality Management Tools. Download the benchmarks. Quality Management Tools Studies. Address process, outcome, and structure-oriented quality assurance issues Establish benchmarks through external database comparisons Compare your performance to establish laboratory goals and improve performance.

Continuous Quality Monitors. Quality Assurance Laboratory Quality Assurance QA encompasses a range of activities that enable laboratories to achieve and maintain high levels of accuracy and proficiency despite changes in test methods and the volume of specimens tested.

A good QA system does these four things: establishes standard operating procedures SOPs for each step of the laboratory testing process, ranging from specimen handling to instrument performance validation; defines administrative requirements, such as mandatory recordkeeping, data evaluation, and internal audits to monitor adherence to SOPs; specifies corrective actions, documentation, and the persons responsible for carrying out corrective actions when problems are identified; and sustains high-quality employee performance.

Laboratory Standardization Laboratory Standardization is achieved when test results have the same analytical accuracy and precision across measurement systems, laboratories, and over time. Links with this icon indicate that you are leaving the CDC website. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website.