
Clinical Laboratory Improvement Amendments
This course provides a comprehensive overview of the Clinical Laboratory Improvement Amendments (CLIA) and the regulatory framework governing laboratory testing in the United States. Participants will examine the purpose and structure of CLIA, including quality systems regulations, certificate types, waived versus nonwaived testing requirements, personnel responsibilities, proficiency testing, competency assessment, calibration verification, and the components of an Individualized Quality Control Plan (IQCP). The course emphasizes the total testing process—preanalytic, analytic, and postanalytic phases—and outlines the administrative, operational, and quality oversight requirements necessary to maintain compliance with federal regulations and ensure accurate, reliable, and timely laboratory test results.
Clinical Laboratory Improvement Amendments
This course provides a comprehensive overview of the Clinical Laboratory Improvement Amendments (CLIA) and the regulatory framework governing laboratory testing in the United States. Participants will examine the purpose and structure of CLIA, including quality systems regulations, certificate types, waived versus nonwaived testing requirements, personnel responsibilities, proficiency testing, competency assessment, calibration verification, and the components of an Individualized Quality Control Plan (IQCP). The course emphasizes the total testing process—preanalytic, analytic, and postanalytic phases—and outlines the administrative, operational, and quality oversight requirements necessary to maintain compliance with federal regulations and ensure accurate, reliable, and timely laboratory test results.

Guidelines in Good Clinical Laboratory Practice
This course will review Good Clinical Laboratory Practice (GCLP) standards that embrace both the research and clinical aspects of GLP utilizing a variety of collected regulatory and guidance material. We will cover eleven core elements that constitute the GCLP standards with the objective of filing ta gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. Other topics include performance of protocol-mandated safety assays, peripheral blood monocular cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials, safety training, quality management program, quality assurance, and reporting.
Guidelines in Good Clinical Laboratory Practice
This course will review Good Clinical Laboratory Practice (GCLP) standards that embrace both the research and clinical aspects of GLP utilizing a variety of collected regulatory and guidance material. We will cover eleven core elements that constitute the GCLP standards with the objective of filing ta gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. Other topics include performance of protocol-mandated safety assays, peripheral blood monocular cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials, safety training, quality management program, quality assurance, and reporting.

Informed Consent
This course refreshes and updates informed consent expectations for U.S. healthcare settings, with a focus on real-world clinical workflows where consent is collected electronically but may revert to paper during downtime (e.g., power outages, high-volume surges, or system interruptions). It emphasizes federally enforceable patient-rights and documentation requirements tied to Medicare and Medicaid participation, while reinforcing ethical principles of patient autonomy and shared decision-making.
The course provides practical, physician-focused guidance for urgent care centers, office-based practices, and higher-acuity referral settings, highlighting how informed consent expectations apply across diverse care environments. Learners will review regulatory distinctions between clinical informed consent and HIPAA authorization, common high-risk consent situations, and documentation practices that support compliance, patient understanding, and continuity of care.
Informed Consent
This course refreshes and updates informed consent expectations for U.S. healthcare settings, with a focus on real-world clinical workflows where consent is collected electronically but may revert to paper during downtime (e.g., power outages, high-volume surges, or system interruptions). It emphasizes federally enforceable patient-rights and documentation requirements tied to Medicare and Medicaid participation, while reinforcing ethical principles of patient autonomy and shared decision-making.
The course provides practical, physician-focused guidance for urgent care centers, office-based practices, and higher-acuity referral settings, highlighting how informed consent expectations apply across diverse care environments. Learners will review regulatory distinctions between clinical informed consent and HIPAA authorization, common high-risk consent situations, and documentation practices that support compliance, patient understanding, and continuity of care.

Protecting Human Subjects
Research with human subject can occasionally result in dilemma. The importance of demonstrating respect for research participants is reflected in the principles used to define ethical research. This course is intended to teach individuals and investigators involved in the design or conduct of human subject research to understand their obligations to protect the rights and welfare of subjects in research. This course covers the
Protecting Human Subjects
Research with human subject can occasionally result in dilemma. The importance of demonstrating respect for research participants is reflected in the principles used to define ethical research. This course is intended to teach individuals and investigators involved in the design or conduct of human subject research to understand their obligations to protect the rights and welfare of subjects in research. This course covers the

Consult Immunoassay Influenza A+B
Influenza is a highly contagious viral infection of the respiratory tract, which is easily transmitted from person to person when an infected person sneezes or coughs. This course covers how to use the McKesson Consult A and B test, which is an in vitro rapid qualitative test that detects influenza A or B nucleoprotein antigens.
Consult Immunoassay Influenza A+B
Influenza is a highly contagious viral infection of the respiratory tract, which is easily transmitted from person to person when an infected person sneezes or coughs. This course covers how to use the McKesson Consult A and B test, which is an in vitro rapid qualitative test that detects influenza A or B nucleoprotein antigens.

OSOM BVBlue Test Application
The OSOM BVBlue Test is an enzyme activity test used to detect sialidase activity in vaginal fluid specimens for women suspected of having Bacterial Vaginosis (BV) infection. This course will cover the general specifications and intended use of the OSOM BVBlue Test, as well as sample collection, routine use, maintenance, and quality control.
OSOM BVBlue Test Application
The OSOM BVBlue Test is an enzyme activity test used to detect sialidase activity in vaginal fluid specimens for women suspected of having Bacterial Vaginosis (BV) infection. This course will cover the general specifications and intended use of the OSOM BVBlue Test, as well as sample collection, routine use, maintenance, and quality control.

Afinion HbA1c Test
The Afinion HbA1c is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin human blood. This course is designed to help participants learn how to effectively use this test by covering general specifications, the step-by-step testing procedure, warnings and precautions, test reporting, interpretation of test results, and the maintenance and quality control of the product.
Afinion HbA1c Test
The Afinion HbA1c is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin human blood. This course is designed to help participants learn how to effectively use this test by covering general specifications, the step-by-step testing procedure, warnings and precautions, test reporting, interpretation of test results, and the maintenance and quality control of the product.

CoaguChek XS
This course reviews the manufacturers instructions for use for the CoaguChek XS System. The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for monitoring warfarin therapy. The system uses fresh capillary or nonanticoagulated venous whole blood. The CoaguChek XS System is for in vitro diagnostic use only.
CoaguChek XS
This course reviews the manufacturers instructions for use for the CoaguChek XS System. The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for monitoring warfarin therapy. The system uses fresh capillary or nonanticoagulated venous whole blood. The CoaguChek XS System is for in vitro diagnostic use only.

Sofia Rapid Strep A+
Group A Streptococcus is one of the most common causes of acute upper respiratory tract infection. The Sofia Strep A+ FIA (Fluorescent Immunoassay Analyzer) detects Group A Streptococcal antigens from throat swabs from patients with signs and symptoms of pharyngitis, such as sore throat. This course covers general operations, routine use, sample collection as well as equipment maintenance and QC.
Sofia Rapid Strep A+
Group A Streptococcus is one of the most common causes of acute upper respiratory tract infection. The Sofia Strep A+ FIA (Fluorescent Immunoassay Analyzer) detects Group A Streptococcal antigens from throat swabs from patients with signs and symptoms of pharyngitis, such as sore throat. This course covers general operations, routine use, sample collection as well as equipment maintenance and QC.
Learning