The waived status is granted according to the difficulty in performing the diagnostic tests Those tests are cleared by the FDA to be done in pts home, but before that, they need to be approved and the application for that process is obtained through the CMS
Which of the following is a CLIA-waived test?
CLIA-waived testing, such as Point of Care Testing, are low complexity tests (including Hemoglobin and Hematocrit) that may be performed by other personnel with proper training
Which agency provides the application for a certificate of waive?
Obtaining a Certificate of Waiver is generally a straightforward process An application (form CMS-116) can be obtained at the CMS Web site or from your state health department
What agency created the guidelines called universal precautions?
Universal precautions were introduced by the Centers for Disease Control (CDC) in 1985, mostly in response to the human immunodeficiency virus (HIV) epidemic
What is the agency that established guidelines concerning contact with blood and body fluids referred to as universal precautions?
The CDC initially defined “universal precautions” as applying to blood and other body fluids containing visible blood See: CDC (1988) “Update: Universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in health-care settings
What is CLIA waived mean?
Waived Testing As defined by CLIA, waived tests are simple tests with a low risk for an incorrect result They include: Certain tests listed in the CLIA regulations Tests cleared by the FDA for home use
What is waived testing?
As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result” The Food and Drug Administration (FDA) determines which tests meet these criteria when it reviews manufacturer’s applications for test system waiver
Who needs a CLIA waiver?
CLIA certification is required for facilities that test clinical specimens for the purpose of diagnosis, treatment, or prevention of disease If your facility only collects specimens to be sent out for testing at another facility, then CLIA certification is not required for your facility
What are the benefits of performing a CLIA waived?
What are the benefits of performing a CLIA-waived rapid test in the medical office? providing the physician with a positive indication of the problem, allowing treatment to be started early, and being convenient for the patient
Who can perform waived testing?
The target audience includes individuals who perform testing in waived testing sites (physician offices, nursing facilities, home health agencies, clinics, pharmacies and other non-laboratory sites) throughout the United States
What are the 3 universal precautions?
Universal precautions include: Using disposable gloves and other protective barriers while examining all patients and while handling needles, scalpels, and other sharp instruments Washing hands and other skin surfaces that are contaminated with blood or body fluids immediately after a procedure or examination
What are the 4 main universal precautions?
Standard Precautions Hand hygiene Use of personal protective equipment (eg, gloves, masks, eyewear) Respiratory hygiene / cough etiquette Sharps safety (engineering and work practice controls) Safe injection practices (ie, aseptic technique for parenteral medications) Sterile instruments and devices
What is the purpose of universal precautions?
Universal precautions are intended to prevent parenteral, mucous membrane, and nonintact skin exposures of health-care workers to bloodborne pathogens In addition, immunization with HBV vaccine is recommended as an important adjunct to universal precautions for health-care workers who have exposures to blood (3,4)
What is OSHA’s bloodborne pathogen standard?
OSHA’S bloodborne pathogens standard protects employees who work in occupations where they are at risk of exposure to blood or other potentially infectious materials OSHA’s hazard com- munication standard protects employees who may be exposed to hazardous chemicals
What is the OSHA regulation that describes employer and employee responsibilities relating to bloodborne pathogens exposure?
Employers must ensure that their workers receive regular training that covers all elements of the standard including, but not limited to: information on bloodborne pathogens and dis- eases, methods used to control occupational exposure, hepatitis B vaccine, and medical eval- uation and post-exposure follow-up
What does OSHA’s bloodborne pathogens standard require of employees?
The OSHA Bloodborne Pathogens Standard emphasizes personal protective equipment or PPE PPE includes gowns, gloves, eye protection, and masks As the employer, you are responsible for cleaning, repairing, and replacing PPE as needed And you must do so at no cost to your employees
What is a CLIA approved lab?
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing Each agency has a unique role in assuring quality laboratory testing
How do you get CLIA waived?
To qualify for a certificate of waiver, your lab must only perform tests that have received the CLIA waived status If you meet this requirement, simply fill out the application form CMS-116 at the CMS website or from your state health The COW is valid for two years
Is a CBC a CLIA waived test?
The Food and Drug Administration (FDA) has granted premarket clearance and a CLIA waiver to Sysmex America for its complete blood cell count (CBC) test, the XW-100 Automated Hematology analyzer
What is the rationale behind waived test?
Waived testing is laboratory testing that employs specific test methods designated under the Clinical Laboratory Improvement Amendments (CLIA) of the Food and Drug Administration (FDA) as “waived” Waived testing is designated by CLIA as simple tests that carry a low risk for an incorrect result
What does the classification of waived test mean quizlet?
Waived tests a Laboratory test that meets the CLIA criteria for being a simple procedure that is easy to perform and has a low risk of erroneous test results waived tests include tests that have been FDA-approved for use by patients at home
What is the purpose of CLIA waived tests quizlet?
Purpose: Urine screeningto asses or diagnose diseases such as diabetes mellitus, kidney disease, and urinary tract infection
How do I check my CLIA status?
You may verify your CLIA certification level and effective dates at: https://wwwcmsgov/Regulations-and- Guidance/Legislation/CLIA/CLIA_Laboratory_Demographic_Information
What is CLIA stand for?
“CLIA” is the acronym for the Clinical Laboratory Improvement Amendments of 1988 This law requires any facility performing examinations of human specimens (eg, tissue, blood, urine, etc) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services
What does CLIA accreditation mean?
In 1988, the US government passed the Clinical Laboratory Improvement Amendments act (CLIA 88 or CLIA), which specified regulations and standards for all facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease
Which of the following occurs when the body is in homeostasis quizlet?
Which of the following occurs when the body is in Homeostasis? Laboratory test results fall within NORMAL RANGE You just studied 25 terms!
What type of tests may assistants perform?
Blood draws and oral swabs are two common forms of testing that medical assistants perform However, in specialized offices, medical assistants may be required to carry out additional assessments, as well
What is the purpose of performing a routine test?
Assists in the diagnosis of pathologic conditions, to confirm a clinical diagnosis, to assist in the differential diagnosis of a patient’s condition, to obtain info regarding a patient’s condition, and provides the physician with essential data List five specific uses of laboratory test results