MedTrainer's Healthcare Course Library

Manual entry of results can lead to a high frequency of errors if precautions are not taken. One study conducted in a POC lab found 3.7% of glucose results were entered incorrectly, and some of those errors could have led to patient harm if not caught.
In this course, we will cover CLIA regulations regarding post analytic systems, common ways errors occur, and possible strategies for preventing errors in reporting test results. CLIA states that a laboratory must have a manual or electronic system that ensures accurate reporting of test results and other patient data, and it gives standards for what must be included in reporting CLIA also specifies that each laboratory must document and follow procedures for assessing the quality of the system for reporting test results.

Calibration and calibration verification are important procedures to substantiate the continued precision and level of quality of a test system within a laboratory. Performed routinely, these procedures will ensure the accuracy of test equipment, minimizing uncertainty and controlling for errors. These are crucial quality control procedures in maintaining a laboratory. In this course, CLIA requirements for calibration and calibration verification will be reviewed.

All laboratory facilities in the United States that perform testing on human specimens for health assessments or the diagnosis, prevention, or treatment of diseases fall under the guidance and regulatory requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Under CLIA, low-risk tests can be waived and performed with no routine regulatory oversight in physicians offices and various other locations. These waived tests include a test system, assay, or examination cleared by the Federal Drug Administration (FDA) for home use or Health and Human Services (HHS) that meets the CLIA criteria of being a simple test with an insignificant risk for an erroneous result.
On the other hand, non-waived tests include complex tests that fail to meet the CLIA criteria for waiver and require training and specific quality measures to ensure the accuracy and reliability of test results (e.g., throat and urine cultures, Rh antigen testing, and glucometer use to perform diagnostic glucose tolerance testing [an intended use not specified in manufacturers instructions]).
In this course, we cover waived versus non-waived testing, the requirements for waived testing, and the regulatory and safety considerations for non-waived testing.

In this course, we will learn the requirements for compliant reporting of laboratory test reports according to the 493.1291 standard test report, including storage of report, timeliness of report transmission, content of the report, maintenance of the report, availability of the report to authorized individuals when requested and required action in special circumstances including when an error is detected in the report , when a report is delayed, or with critical results.

Validation is the provision of objective evidence through a defined process that a test performs as intended. In this course, we will review why a laboratory must undertake validation, its unique components, and the different types of validation. We will also review what non-waived tests are FDA approved.

This course provides an understanding of what Phlebotomy is and its uses to perform medical testing, transfusions, or donation. Furthermore, it will help with more details surrounding diagnosis, procedure to obtain blood samples, treatment of diseases, and best practices of collection procedures.

This course introduces the key differences between calibration and calibration verification and explains why both processes are essential for maintaining accurate laboratory instrument performance and reliable patient test results. Learners review CLIA and CMS expectations, the role of manufacturer instructions, reportable range and analytical measurement range concepts, required calibration verification materials, timing requirements, exceptions, documentation expectations, and steps to take when calibration verification fails or instrument bias is suspected.

This basic-level eLearning course is the first of a two-part introductory module on laboratory informatics. The course provides information on the role and processes of laboratory informatics through exploration of the “life of a specimen” as a specimen moves through the laboratory. Topics covered include the roles of various personnel in the laboratory informatics enterprise, data relationships, data quality and standards, and the generation and flow of information as a specimen progresses through the pre-analytic, analytic, and post-analytic phases.
Learners who complete this course can then take the second course in the two-part module – Introduction to Laboratory Informatics: Life of a Result

A chemical fume hood is the main piece of laboratory equipment that protects laboratory staff working with hazardous chemicals. When properly used, fume hoods protect staff from inhaling chemical gases, vapors, and aerosols. They serve as a physical barrier between staff and the hazardous materials inside the hood, and provide some splash protection.
This basic-level eLearning course provides an essential understanding of the major components of a chemical fume hood and proper practices for its safe and effective operation. Topics covered include the major components and types of fume hoods and their monitors, maintaining proper airflow, daily use protocols and good fume hood work practices, and what to do if there is an emergency.