Dee Posted March 14, 2011 Share Posted March 14, 2011 (edited) Our facility performs an ABORh recheck on patients that do not have a historical blood type on file. We have an employee that is working in our area but is not a medical technologist. She completed nursing school but did not pass the national test. Part of her responsibilities have included ABORh rechecks of patients and donor unit check-in. Our new lab director states that due to CLIA regulations, she can not continue to perform these rechecks. Is this your interpretation? Edited March 14, 2011 by Dee Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted March 14, 2011 Share Posted March 14, 2011 Being in England, I don't know, but, considering the ABO type is the single most important test performed in the Blood Bank, and given the history of this employee, I'm not sure that I would be particularly happy with them doing this test.Okay if they all agree; but if they don't............... Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted March 14, 2011 Share Posted March 14, 2011 Being in England, I don't know, but, considering the ABO type is the single most important test performed in the Blood Bank, and given the history of this employee, I'm not sure that I would be particularly happy with them doing this test.Okay if all the results agree; but if they don't............... Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted March 14, 2011 Share Posted March 14, 2011 Being in England, I don't know, but, considering the ABO type is the single most important test performed in the Blood Bank, and given the history of this employee, I'm not sure that I would be particularly happy with them doing this test.Okay if all the results agree; but if they don't...............:ohmygod::ohmygod: Link to comment Share on other sites More sharing options...
Bill Posted March 14, 2011 Share Posted March 14, 2011 According to CLIA regulations, Moderate Complex testing (ABORh is considered this) must be performed by a medical laboratory technician or medical technologist. If this person does not meet the educational standards for either, then she cannot perform the tests. Link to comment Share on other sites More sharing options...
L106 Posted March 14, 2011 Share Posted March 14, 2011 I believe Bill is correct. (We used to have a Lab Aide who did the ABO/Rh recheck on donor units, but we had to stop that years ago because of CLIA regulations.) Link to comment Share on other sites More sharing options...
Mabel Adams Posted March 15, 2011 Share Posted March 15, 2011 I wouldn't think that retyping units would be considered "patient testing" which is what CLIA covers. It is more a matter of blood product manufacturing I would think and thus would be covered by FDA cGMP rules. Link to comment Share on other sites More sharing options...
Susan.Sullivan Posted March 15, 2011 Share Posted March 15, 2011 I would refer you to the CFR std 493.1423 & 493.1425. The standard subpart (2) HAVE EARNED AN ASSOCIATE DEGREE IN CHEMICAL, PHYSICAL OR BIOLOGICAL SCIENCE, OR MEDICAL TECHNOLOGY FROM AN ACCREDITED INSTITUTION Link to comment Share on other sites More sharing options...
Mabel Adams Posted March 16, 2011 Share Posted March 16, 2011 (4)(i) Have earned a high school diploma or equivalent; and (ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has (A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; ( The skills required for implementing all standard laboratory procedures; © The skills required for performing each test method and for proper instrument use; (D) The skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed; (E) A working knowledge of reagent stability and storage; (F) The skills required to implement the quality control policies and procedures of the laboratory; (G) An awareness of the factors that influence test results; and (H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results.Read more: http://cfr.vlex.com/vid/1423-standard-testing-qualifications-19809781#ixzz1Giw2Kbv9The above is most of the rest of 493.1423 which shows that there are some other legal ways to be qualified. I wouldn't be very willing to let anyone of limited qualification do patient testing, but retyping of units seems less risky. Link to comment Share on other sites More sharing options...
ejsommers Posted May 12, 2011 Share Posted May 12, 2011 Mabel - I think Dee said the assistant was retyping patients w/o a hx and not retyping units. Link to comment Share on other sites More sharing options...
Mabel Adams Posted May 13, 2011 Share Posted May 13, 2011 "Part of her responsibilities have included ABORh rechecks of patients and donor unit check-in."I assumed that "donor unit check-in" included retyping the units. Link to comment Share on other sites More sharing options...
tbostock Posted May 13, 2011 Share Posted May 13, 2011 Would not be allowed in NY State with our licensing. I would also never allow anyone without Blood Bank education and training to perform a blood type (patient or unit). Link to comment Share on other sites More sharing options...
Eagle Eye Posted May 14, 2011 Share Posted May 14, 2011 Same as Terry. Link to comment Share on other sites More sharing options...
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