MedTrainer's Healthcare Course Library

Document Control in the Clinical Laboratory Setting

Laboratory documentation is a term to describe standard operating procedures, equipment logs, files, reports, records, and printed materials that come with instruments and test kits provided by a manufacturer. Documentation is the virtual ecosystem of the clinical lab which ensures consistency and quality of services, as well as compliance with OSHA and CLIA regulations. In this course we will review the best practices for controlling the processes that ensure only current and approved documentation is available and utilized. Laboratory documents provide the means to review laboratory activities proof that patient testing is accurate, precise, and reliable.

Health Insurance Portability and Accountability Act (HIPAA) in the Laboratory Setting

HIPAA Privacy and Security Rules have significantly changed the way health care facilities and healthcare providers operate. The Health Insurance Portability and Accountability Act, also known as HIPAA, along with privacy, security, and breach notification rules protect the privacy and security of all health information, including laboratory test results. These rules also provide individuals with certain rights to their specific health information. As someone working in a laboratory setting, you play a critical role in protecting the privacy and security of patient information. This course is designed for laboratory personnel, from administrative assistants, to medical technologists, and everyone on staff that may have access to protected health information. In this course we will review the best practices for maintaining HIPAA compliance, and explore the importance safeguarding various systems that house protected health information.

Laboratory Director Responsibilities

According to CLIA regulations, laboratory directors are responsible for the overall operation of their laboratories. The term overall operation encompasses many different individual responsibilities, and they must all be met to ensure compliance with all applicable regulations. The role of laboratory director is one of great responsibility. A significant amount of time, energy, and resources must be invested to fulfill the requirements of the role appropriately. This course will discuss the responsibilities of a laboratory director as detailed by CLIA, COLA, and other pertinent organizations.

Clinical Laboratory Improvement Amendments

The Centers for Medicare and Medicaid Services regulate all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The purpose of the CLIA program is to ensure quality laboratory testing. Learning about the format, terminologies, and requirements enacted in CLIA will help you keep your laboratory in compliance. Course expiration date: 9/10/2024

CLIA Waived Lab Fire Safety and Fire Extinguisher Types and Techniques

The best time to learn how to handle a fire emergency is before you find yourself in a fire emergency.

Fire is a serious hazard in the clinical laboratory setting. Numerous electrical and chemical hazards can turn a small bench-top fire into a large uncontrolled blaze if lab personnel do not strictly adhere to fire safety guidance and best practices.

Fires in the clinical laboratory can be managed, and risk of fire minimized, by properly following fire safety guidelines, including compliance with OSHA rules and regulations. In this course, we review best practices for preventing and handling fires in the clinical laboratory setting. The types of fire extinguishers found in the laboratory, and proper technique for their use, is also covered. Proper knowledge of fire safety and fire extinguishers helps keep lab personnel safe and maintains a safe working environment.

CLIA Waived Patient ID and Test Strip Labeling

Patient identification test strip labeling ensures positive patient identification through specimen collection, labeling, accessioning, processing, (e.g., aliquoting), storage, testing, and reporting of results. Importantly, review the laboratorys system (policy and practices) for ensuring positive patient identification from specimen collection through reporting of results; each clinical laboratory implements specific laboratory practices to ensure compliance with OSHA and CLIA regulations.

Proper labeling ensures consistency and quality of services, as well as compliance with OSHA and CLIA regulations. In this course we review good laboratory practices, regulatory and safety considerations, and implementation of best practices for patient identification test strip labeling.

This course also provides case study examples, which allow the student to demonstrate an understanding of the course objectives and learning targets.

CLIA Waived First Time Waived Testers

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.

Clinical laboratories that conduct only waived testing are required to have a valid Certificate of Waiver (COW) from CLIA. For clinical laboratories to qualify for this CLIA COW, they must only perform waived tests as defined by CLIA. As part of compliance investigations, these laboratories are inspected to ensure that they are indeed performing only waived testing. Human Health Services will limit, suspend, or revoke a laboratorys Certificate of Waiver for failing to comply with State Operations Manual requirements. In this course, we cover waived testing as outlined by CLIA, the requirements for laboratories to qualify for a CLIA Certificate of Waiver (COW), and the CLIA COW application process for first-time waived testers.

High-Level Disinfection

This course focuses on the importance of compliance with best practices related to instrument reprocessing and provides an overview of the essential steps within a high-level disinfection process.

Iceberg Model and Functional Behavior Assessment

Recorded webinar, non-interactive, self-paced with Pre-test and post test. For CE credits, you must take the course in the external site.