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Terms in this set (35)This certificate is issued to a laboratory to perform only waived tests. Certificate of Waiver (COW) certificate is issued to a laboratory who performs no moderate-complexity tests other than the PPMP procedures Certificate for PPMP. This certificate enables the entity to conduct moderate- and high-complexity laboratory testing until the entity is determined by survey to be in compliance with CLIA regulations Certificate of Registration This certificate is issued to a laboratory after an inspection finds the laboratory to be in compliance with all applicable CLIA requirements. (Moderate complexity test) Certificate of Compliance This is a certificate that is issued to a laboratory on the basis of the laboratory's accreditation by an organization approved by CMS. (High complexity test) Certificate of Accreditation All five certificates require renewal every _______ years 2 After a laboratory has been certified, it must notify CMS within _____ months if it changes the type of tests it performs. 6 CMS form 116 for the clinical laboratory collects information regarding a laboratory's operation and is needed to *evaluate fees Each person who takes the tests must be *licensed by the state if required All high-complexity tests must be done by technologists and technicians (except for cytology) The following criteria are used to categorize moderate- and high-complexity tests. *The degree of operator intervention needed To be categorized as a PPMP, the procedure must meet the following criteria: *The examination must be personally performed by one of the following practitioners: A provider, midlevel practitioner, under the supervision of the provider, dentist waived tests are simple laboratory examinations and procedures that are cleared by the FDA for home use CLIA '88 regulations require that three different procedures be performed in the quality-control protocol for automated hematology instruments which are *calibration CLIA's three categories of testing *Waived tests PPMP tests are ______ test moderate-complexity CLIA '88 regulations are based on the complexity of tests performed and they affect all aspects of the laboratory. CLIA specifies *the type of test performed The purpose of CLIA '88 is to safeguard the public by regulating all testing of specimens taken from the human body. (protects patients) The purpose of OSHA is to require employers to ensure employee safety in regard to occupational exposure to potentially harmful substances. (Protects workers) Two OSHA standards have the greatest impact: *The Occupational Exposure to
Hazardous Chemicals (revised from The Hazard Communication Standard) OSHA published its Hazard Communications Standard to reduce the number of chemically related illnesses and injuries in the workplace The Chemical Hygiene Plan (CHP) on hazardous chemicals is The core of the OSHA safety standard on hazardous chemicals All laboratories and ambulatory care settings, including providers' offices, must comply with a chemical hygiene plan to meet the OSHA regulations. There are three primary goals that an employer must accomplish to be in compliance with the OSHA standard for chemical exposure *must be an inventory
taken and a list compiled of all chemicals considered hazardous There are four colors of the MSDS manual *Blue Blue signifies a health hazard Red signifies a flammability hazard Yellow signifies reactivity or instability hazard White signifies a special hazard and the use of personal protective equipment (PPE) The numbers 0 to 4 are used in conjunction with the colors to indicate the level of risk for each product and are assigned by the manufacturer using the rating system Chemicals on the skin should be washed Immediately and continue for 5 minutes Chemicals in the eyes Should be rushed for 15 minutes Cumulative trauma disorders are injuries involving the musculoskeletal or nervous system Cumulative trauma disorders are a result in long-term, repetitive work actions Sets with similar termsPhlebotomy ch 3883 terms kristen_rowell Skills 2: Chapter 38 & 39 NOTES100 terms Hia_Abbuhl Chapter 3829 terms Tasha_Loughlin Sets found in the same folderPhlebotomy264 terms Kirsy_Loud Med Terms Ch 3292 terms kirang57 Anatomy Unit 252 terms Amyalfieri Vital Signs #2 (HW)11 terms angelaxirene Other sets by this creatorClinicals Chapter 3072 terms kmcunningham86 Clinicals Chapter 3162 terms kmcunningham86 Clinicals Chapter 2491 terms kmcunningham86 Urinalysis Chapter 4422 terms kmcunningham86 Related questionsQUESTION Last year there was a horrible outbreak of flu. 2 answers QUESTION What is better: dietary calcium or calcium supplementation? 6 answers QUESTION What is the transmission of the plague 15 answers QUESTION Which person below should not receive the anthrax vaccine? 6 answers What is the difference between moderate and high complexity testing?Low scores indicate low complexity, with tests obtaining a total score of ≤12 being categorized as moderate complexity. Tests with final scores >12 are categorized as high complexity.
What is considered a high complexity test?High complexity tests include those that require clinical laboratory expertise beyond normal automation to perform. If the output of the data requires some expertise, these would also be highly complex.
What are the three categories of testing under CLIA?Current Regulation: CLIA established three categories of tests: waived tests, moderate complexity tests, and high complexity tests.
What are the three different levels of laboratory testing?There are three phases of laboratory testing: Pre-analytical (pre-testing phase) Analytical (testing phase) Post-analytical (post-testing or reporting phase)
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All of the following criteria are used to categorize moderate- and high-complexity tests except:
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