Not only are quality assessment and quality control important in a physician’s office laboratory, but the medical assistant must avoid exposure to health and safety risks in the laboratory. Medications discontinued a. b. Categories of Test Results. CLIA '88 was made law to regulate: a. the disposal of infectious waste b. the use of chemicals in the workplace c. laboratory tests performed on specimens taken from the human body d. the transmission of the human immunodeficiency virus (HIV) Congratulations to all our graduates who were placed in their field of choice this week! 4. FilmArray ® RP EZ detects 11 viral and 3 bacterial pathogens associated with respiratory infections from a single patient sample and is a simplified version of the CE - IVD, FDA-cleared FilmArray ® Respiratory Panel (RP). Ventricular recovery or repolarization of the ventricles is indicated by the: T-Wave. The CLIA requirements for testing under a Certificate of Waiver can be found here: http://wwwn.cdc.gov/clia/Regulatory/default.aspx Waived test: Laboratory test that has been determined by CLIA to be: - - 3. a. Waived tests include test systems cleared by the Food and Drug Administration (FDA) for home use and those tests approved for waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) criteria. a. b. c. Interpretation of qualitative results . Laboratory tests: a. CLIA has established three levels of testing based on the complexity of a test. 15-PAGE 2 Content Outline Copyright � 2012, 2008, 2004, 2000, 1995, 1990, 1984, 1979 by Saunders, an imprint of Elsevier Inc. Performs phlebotomy duties as directed. The results of the laboratory testing are compared to the acceptable ranges in a healthy population to determine the health of the body system or organ tested. These amendments were passed by the Congress way back in 1988. When a physician orders a laboratory test, there are certain tests that can be done by a medical assistant with on site equipment and some that must be done at an off-site medical laboratory. Medical testing may be a lifesaving procedure for your patients. This includes specimen collection, processing, preservation, and transportation. Most laboratory tests are performed on specimens that are easily obtained a. b. c. d. e. f. Samples of secretion or discharge for microbiologic analysis 6. There a few different types of clinical laboratories used by physicians’ offices. A clinical laboratory registered by the California Department of Public Health must hold either a valid CLIA Certificate of Waiver or a valid CLIA Certificate of Provider-Performed Microscopy. Can I perform tests other than waived tests if I have a Certificate of Waiver? All laboratories, including physicians’ office laboratories, must have a CLIA certificate to meet federal requirements. This booklet describes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a CLIA Certificate of Waiver. Some waived tests include glucose monitoring, urine dipstick analysis, pregnancy testing, and fecal occult blood packets. The list has been expanded, containing some methods of rapid strep antigen, infectious mono, H. pylori and cholesterol testing. Categories of Test Results 1. Based on your understanding of these tests, summarize at least five of them, along with their functions. waived tests. Students perform Clinical Laboratory Improvement Amendment (CLIA) waived routine laboratory procedures commonly performed in the … What should a medical assistant perform to maintain quality control for CLIA-waived tests in the physician's office laboratory? The levels include waived tests, moderate complexity tests, and high complexity tests. Place the following steps in order that are needed to collect a throat specimen in the correct order. © 2021 Hunter Business School The government requires a certificate of waiver to perform waived tests. 3 Any clinical laboratory that performs waived tests only is exempt from state licensure requirements and state surveys. There are some basic equipment and supplies that are common to most physicians’ office laboratories. Clinical chemistry: Largest area in clinical chemistry: blood chemistry c. Serology and blood banking: d. Urinalysis: e. Microbiology: Examples of specimens - - - - - - - - f. Parasitology: Examples of specimens - - - g. Cytology: h. Histology: 3. Fasting: a. Please verify your tests waived status and CPT code prior to implementing testing. The quality assessment plan will monitor the patient preparation procedure. The other tests listed in this scenario are performed by methods in a higher complexity category by CLIA standards. Medications 10. ... Graduate of an accredited program for Medical Assistants. Source of specimen (e.g., throat, wound, ear, eye, urine, vagina) 8. Waived tests a. b. - Hunter Business School ... See MoreSee Less, What Is the Medical Assistant's Role in Phlebotomy? MA should have knowledge of laboratory tests performed most often a. b. c. d. 4. Laboratory Directory 1. a. It’s a technical skill requiring both clerical and clinical expertise, making it an ideal assignment for a medical assistant. Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA … practices for physicians, nurses, medical assistants and others performing patient testing under a CLIA Waiver Certificate oCDC also offers an on-line training course corresponding to “Ready, Set, Test”. Good News Monday Medford! (Business and Professions Code (BPC) § 1209)(a)) 1. ... See MoreSee Less, 3601 Hempstead Tpke 631.736.7360. They must also arrange for appropriate specimen transport if needed. Purpose of Laboratory Testing 1. a. to collect information about waived tests. Appropriate training in the methodology of the test being performed. - Hunter Business School, Share on FacebookShare on TwitterShare on Linked InShare by Email, It is our favorite day of the week! There are over 1,400 test systems that have been waived. Date and time of collection of specimen 5. The most A certificate of CLIA PPM (Provider Performed Microscopy)allows the facility to perform only tests categorized as CLIA waived or PPM. The CLIA personnel requirements are found in Subpart M of the Code of Federal Regulations. Homeostasis: 3. 3.Depress the tongue with a tongue depressor. CLIA waiver permits use of the test outside traditional clinical laboratories in sites such as physician offices and urgent care centers. CLIA-Waived Laboratory Testing. The CLIA requirements for testing under a Certificate of Waiver can be found here: http://wwwn.cdc.gov/clia/Regulatory/default.aspx List seven regulations of the Clinical Laboratory Improvement Act (CLIA) that apply to the clinical medical assistant performing urine testing. Pathologic condition a. For a list of waived tests sorted by analyte name, visit the FDA website at: CLIA – Currently Waived Analytes. What Is the Medical Assistant's Role in Phlebotomy? It is our favorite day of the week! Good News Monday Levittown! The physician’s office laboratory must have written policies and procedures for monitoring quality control for the accuracy, precision, and quality of each test. Results in imbalance in the body - b. c. d. Must use a combination of data from: - - - Laboratory Tests 1. State Agency. The medical assistant’s duties include educating patients about the use of point-of-care tests and machines to assure accurate results. Your consent is not required to obtain information regarding Hunter Business School or its vocational programs. From the list below, select the correct syringe, angle, and site. 2.Remove the sterile swab, being careful not to contaminate it. Please select one of our other health care related programs. spun hematocrit, urine hcg, rapid strep The medical assistant is preparing to administer a Mantoux test. The control log must include the date and time of the test, the results expected, the results obtained, action taken for corrections if needed, and the initials of the person performing the 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. All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The Clinical Laboratory Improvement Amendments (CLIA) program regulates laboratories that test human specimens and ensures they give accurate, reliable, and timely patient test results regardless . Most tests performed by medical assistants would fall under the CLIA category of? Categories of laboratory testing are based on complexity of testing methods 2. 4.Do not allow the swab to touch any areas other than the throat. The FDA list of waived tests is continuously being updated. It is important to keep strict quality control and quality assurance standards while obtaining specimens, transporting them, and obtaining the test results. : Bonewit: Clinical Procedures for Medical Assistants, 8th Edition Chapter 15: Introduction to the Clinical Laboratory Introduction to the Clinical Laboratory 1. The medical assistant working in the physician’s office laboratory collects samples, performs tests, follows strict procedures, manages quality control, maintains laboratory equipment, keeps accurate records, prepares specimens for transport to reference or off-site laboratories, and reports results to the physician. CLIA-waived tests most frequently performed in the medical office: i. Many times, a test may rule out a disease or suggest that additional testing be performed. CLIA divides laboratories into three categories: waived, moderate complexity, and high complexity .Each category specifies the types of tests that may be performed. These terms do not relate directly to the test complexity categories, and it cannot be assumed that a test system is waived simply because it is performed at the point of care. Medical assistants will need to document and maintain a quality assurance program. A medical assistant will need to be familiar with the types of specimens presented to be able to determine which tests to order. 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