Learning
Credentialing
Compliance
Quality Control/Calibrator use and frequency
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.
Quality Control/Calibrator use and frequency
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.
CLIA Waived vs. Non-Waived Testing
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.
CLIA Waived vs. Non-Waived Testing
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.
Requirements for Compliant Test Reporting
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.
Requirements for Compliant Test Reporting
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.
Validations Requirements in a Non-Waived (Moderately Complex) Laboratory environment
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.
Validations Requirements in a Non-Waived (Moderately Complex) Laboratory environment
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.
Phlebotomy Overview and Specimen Collection Procedures
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.
Phlebotomy Overview and Specimen Collection Procedures
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.
Calibration vs. Calibration Verification
Calibration and calibration verification are crucial processes in maintaining the accuracy of a laboratorys instruments. In this course, we will review why these processes are important, what is required, why labs must participate, and discover which category of laboratory tests to which they apply.
Calibration vs. Calibration Verification
Calibration and calibration verification are crucial processes in maintaining the accuracy of a laboratorys instruments. In this course, we will review why these processes are important, what is required, why labs must participate, and discover which category of laboratory tests to which they apply.
Fundamentals of Working Safely in a Biological Safety Cabinet
A biological safety cabinet (BSC) is the primary means of containment developed for working safely with infectious microorganisms. Class II BSCs, the most common cabinets used in laboratories, is designed to provide personnel protection (for you and those around you), product protection (for your samples), and environmental protection. This basic-level eLearning course provides information on the safe use of Class II biological safety cabinets. Topics covered include major parts of a BSC, how a BSC works, how to work safely inside a BSC, and what to do if there is an emergency while working in a BSC. Videos, interactive exercises, job aids, and a modifiable checklist template are included in the course to enhance the learning experience.
Fundamentals of Working Safely in a Biological Safety Cabinet
A biological safety cabinet (BSC) is the primary means of containment developed for working safely with infectious microorganisms. Class II BSCs, the most common cabinets used in laboratories, is designed to provide personnel protection (for you and those around you), product protection (for your samples), and environmental protection. This basic-level eLearning course provides information on the safe use of Class II biological safety cabinets. Topics covered include major parts of a BSC, how a BSC works, how to work safely inside a BSC, and what to do if there is an emergency while working in a BSC. Videos, interactive exercises, job aids, and a modifiable checklist template are included in the course to enhance the learning experience.
Introduction to Laboratory Informatics: Life of a Specimen
Laboratory informatics is the specialized application of information technology to enable and enhance scientific processes and the delivery of laboratory information. It is a critical part of todays laboratory operations, helping to ensure high quality and reliable data and results.
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.
Introduction to Laboratory Informatics: Life of a Specimen
Laboratory informatics is the specialized application of information technology to enable and enhance scientific processes and the delivery of laboratory information. It is a critical part of todays laboratory operations, helping to ensure high quality and reliable data and results.
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.
Fundamentals of Chemical Fume Hood Safety
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.
Fundamentals of Chemical Fume Hood Safety
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.