Moderately complex testing personnel
[DOC File]Procedure: CLIA – waived for urine samples; Moderately ...
https://info.5y1.org/moderately-complex-testing-personnel_1_1c6ffc.html
On-site testing of one nasal swab or nasopharyngeal swab or a portion of nasopharyngeal aspirate/wash specimen in the Sofia Influenza A+B FIA test was performed on the fresh specimen by medical personnel in the physician’s office or hospital facility. The remaining sample was placed in …
[DOC File]LOURDES HOSPITAL
https://info.5y1.org/moderately-complex-testing-personnel_1_3a3a97.html
: Analytical patient testing activities provided within the institution, but performed outside the physical facilities of the clinical laboratory at or near the site of patient care. Point of Care testing is classified by the FDA as Waived or Moderately Complex based on the complexity, skill and knowledge needed to perform the test. Waived Testing
[DOC File]Procedure; Competency Testing - Michigan
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Whenever a new test method is added or an existing procedure is modified substantially, all testing personnel must demonstrate competency in performing the new (or altered) test procedures. Specimen: Competency evaluations will be performed using clinical specimens (e.g., serum, whole blood, or urine), proficiency testing specimens, or quality ...
[DOCX File]SUMMARY
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Moderately complex test requires basic laboratory knowledge and training of personnel performing the tests. Moderately Complex Tests (MCT’s) may require reagent preparation, limited pretreatment of specimens, quality control, calibration, proficiency testing, some skill in troubleshooting and maintaining equipment, and some skill or judgement ...
[DOC File]Laboratory: _________________________________________ Date ...
https://info.5y1.org/moderately-complex-testing-personnel_1_b815e9.html
This is a Waived Complexity and Moderately Complex test. Intended Use. The Sure-Vue® Strep A Test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. ... Testing Personnel …
CHAPTER 59A-7 CLINICAL LABORATORIES
(20) Moderately Complex Test – procedures defined as moderately complex by the federal Health Care Financing Administration under the federal Clinical Laboratory Improvement Amendments of 1988 and federal rules adopted thereunder. ... is held responsible for proper performance of testing procedures, testing personnel, reporting of results and ...
59A-7
1. Ensure that testing personnel are limited to those who meet the requirements of paragraph 59A-7.034(7)(a), F.A.C., and, 2. Establish methods for the evaluation of competency to verify that alternate-site testing personnel perform procedures and report tests results promptly and accurately. Evaluation of competency shall include: a.
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