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, 201114 yr by Dee

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...............

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...............

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:

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.

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.)

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.

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

(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#ixzz1Giw2Kbv9

The 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.

Mabel - I think Dee said the assistant was retyping patients w/o a hx and not retyping units.

"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.

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).

Same as Terry.