Learning
Credentialing
Compliance
CLIA Waived Ongoing Waived Testing Requirements for Influenza, Strep, Mono, HC
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.
These CLIA regulations require a facility to appropriately certify each waived test performed. The latest tests approved by the FDA as waived tests under CLIA can be found in the appropriately-dated versions of the Centers for Medicare and Medicaid Services (CMS) Online Manual System, New Waived Tests Transmittal, Recurring Update Notification attachments. Effective dates and descriptions are provided in these notifications for each of the latest FDA approved tests (e.g., 87502QW, May 28, 2019, Alere ID NOW Instrument {Nasal and Nasopharyngeal swabs}, for Influenza A/B). Each CLIA-approved facility recognizes that the associated Current Procedural Terminology (CPT) codes (e.g., 87502QW) indicate which newly FDA-approved tests meet waived test criteria. The Healthcare Common Procedure Coding System (HCPCS) has its own guidelines and is based on these American Medical Association CPT codes.
In this course, we cover the purpose for Recurring Update Notifications of waived tests, CPT codes for waived tests associated with these Recurring Update Notifications, and current Recurring Update Notifications for Influenza, Strep, Mono, and HCG (urine vs. serum), etc.
CLIA Waived Ongoing Waived Testing Requirements for Influenza, Strep, Mono, HC
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.
These CLIA regulations require a facility to appropriately certify each waived test performed. The latest tests approved by the FDA as waived tests under CLIA can be found in the appropriately-dated versions of the Centers for Medicare and Medicaid Services (CMS) Online Manual System, New Waived Tests Transmittal, Recurring Update Notification attachments. Effective dates and descriptions are provided in these notifications for each of the latest FDA approved tests (e.g., 87502QW, May 28, 2019, Alere ID NOW Instrument {Nasal and Nasopharyngeal swabs}, for Influenza A/B). Each CLIA-approved facility recognizes that the associated Current Procedural Terminology (CPT) codes (e.g., 87502QW) indicate which newly FDA-approved tests meet waived test criteria. The Healthcare Common Procedure Coding System (HCPCS) has its own guidelines and is based on these American Medical Association CPT codes.
In this course, we cover the purpose for Recurring Update Notifications of waived tests, CPT codes for waived tests associated with these Recurring Update Notifications, and current Recurring Update Notifications for Influenza, Strep, Mono, and HCG (urine vs. serum), etc.
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 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.
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.
CLIA Waived Reducing Errors and Injuries in Phlebotomy
Phlebotomy is the act of making a puncture in a vein in order to draw blood. This procedure is exceptionally common in health care and medical research. Great care and precision must be practiced in order to limit and reduce any injuries and errors to the patient and the blood sample. This course will cover the types of errors and injuries that may occur in phlebotomy, as well as tips and best practices recommended by the World Health Organization to reduce these errors and injuries.
CLIA Waived Reducing Errors and Injuries in Phlebotomy
Phlebotomy is the act of making a puncture in a vein in order to draw blood. This procedure is exceptionally common in health care and medical research. Great care and precision must be practiced in order to limit and reduce any injuries and errors to the patient and the blood sample. This course will cover the types of errors and injuries that may occur in phlebotomy, as well as tips and best practices recommended by the World Health Organization to reduce these errors and injuries.
CLIA Waived Reading Package Inserts
Package inserts inside medications are documents detailing information about the drug and the use of the drug. These inserts provide vital information for medical professionals and patients to ensure proper prescription and use of the medication. It is important for medical professionals and patients to properly understand how to read and follow these package inserts for the safety of the patient. This course will cover how to appropriately read package inserts inside medications.
CLIA Waived Reading Package Inserts
Package inserts inside medications are documents detailing information about the drug and the use of the drug. These inserts provide vital information for medical professionals and patients to ensure proper prescription and use of the medication. It is important for medical professionals and patients to properly understand how to read and follow these package inserts for the safety of the patient. This course will cover how to appropriately read package inserts inside medications.
CLIA and Staff Competency: Meeting the Regulatory Requirements
Competency is defined by the Centers for Medicare and Medicaid Services as the ability of personnel to apply their skill, knowledge, and experience to perform their laboratory duties correctly. On completion of this course, you will be able to understand the necessary regulatory requirements for competency assessment for all personnel conducting laboratory testing.
CLIA and Staff Competency: Meeting the Regulatory Requirements
Competency is defined by the Centers for Medicare and Medicaid Services as the ability of personnel to apply their skill, knowledge, and experience to perform their laboratory duties correctly. On completion of this course, you will be able to understand the necessary regulatory requirements for competency assessment for all personnel conducting laboratory testing.
Introduction to Clinical Laboratory Improvement Amendments of 1988 (CLIA)
The goal of this course is to equip learners with foundational information about CLIA, including the history, its importance, and implications for clinical laboratories and facilities that perform testing that are subject to the regulations.
This basic-level eLearning course provides information on selected CLIA regulations. Topics covered include CLIA Regulatory Program Overview, CLIA Laboratory Testing and Quality Standards, and CLIA Program Oversight and Administration.
Introduction to Clinical Laboratory Improvement Amendments of 1988 (CLIA)
The goal of this course is to equip learners with foundational information about CLIA, including the history, its importance, and implications for clinical laboratories and facilities that perform testing that are subject to the regulations.
This basic-level eLearning course provides information on selected CLIA regulations. Topics covered include CLIA Regulatory Program Overview, CLIA Laboratory Testing and Quality Standards, and CLIA Program Oversight and Administration.
CLIA and Provider Performed Microscopy (PPM) Procedures: An Introduction
The goal of this eLearning course is to prepare physicians, midlevel providers, dentists, and others to meet requirements for PPM procedures under a CLIA certificate.
This basic-level eLearning course provides information on selected topics, including: background of PPM procedures, overview of criteria, examinations, and regulations, how to apply for a CLIA Certificate for PPM Procedures, requirements for PPM personnel, and additional CLIA requirements and quality practices.
CLIA and Provider Performed Microscopy (PPM) Procedures: An Introduction
The goal of this eLearning course is to prepare physicians, midlevel providers, dentists, and others to meet requirements for PPM procedures under a CLIA certificate.
This basic-level eLearning course provides information on selected topics, including: background of PPM procedures, overview of criteria, examinations, and regulations, how to apply for a CLIA Certificate for PPM Procedures, requirements for PPM personnel, and additional CLIA requirements and quality practices.
Trauma-Informed Care in Community Health Centers
The economic and social consequences of the pandemic are particularly acute for children and adults, suffering from the long-term effects of Adverse Childhood Experiences (ACE). Health issues for this patient population are often manifested into mental and physical illnesses due to the overwhelming isolation of social distancing, economic disparities, and the uncertainty caused by the pandemic.
Patients of all ages that struggle with chronic physical or mental illnesses are often viewed critically by others as having contributed to their illnesses primarily due to lifestyle choices and high-risk behaviors. According to the American Academy of Pediatrics, healthcare questions often focus on what is wrong with you rather than what happened to you?.
In this webinar, we will discuss the effects of adverse childhood experiences on children and adults, and how the pandemic may be a trigger for unhealthy choices, substance abuse, despair, suicidal tendencies, hostility, violence, or any combination of these unhealthy reactions. We will review the importance and tactics for trauma-informed care and available resources.
Trauma-Informed Care in Community Health Centers
The economic and social consequences of the pandemic are particularly acute for children and adults, suffering from the long-term effects of Adverse Childhood Experiences (ACE). Health issues for this patient population are often manifested into mental and physical illnesses due to the overwhelming isolation of social distancing, economic disparities, and the uncertainty caused by the pandemic.
Patients of all ages that struggle with chronic physical or mental illnesses are often viewed critically by others as having contributed to their illnesses primarily due to lifestyle choices and high-risk behaviors. According to the American Academy of Pediatrics, healthcare questions often focus on what is wrong with you rather than what happened to you?.
In this webinar, we will discuss the effects of adverse childhood experiences on children and adults, and how the pandemic may be a trigger for unhealthy choices, substance abuse, despair, suicidal tendencies, hostility, violence, or any combination of these unhealthy reactions. We will review the importance and tactics for trauma-informed care and available resources.