Lab Director for PPMP or Waived sites

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I am in the middle of a total revamp of our CLIA licenses right now. We have 66 and I am going to be getting that down to around 20 with Multi-Site licenses. I am having a couple physicians who have been picked as Lab Directors for some of the groups request to know exactly what that means. We do not have anything in writing so I thought I would ask what other groups have.


I have generally told them that they are responsible for all the testing at the location they are covering. I am not meaning that they are going to be doing it but if any action is taken by the state it's will untimely come to them as the lab director. I will be monitoring them like I always do and when any major issue is found at a particular clinic they will be added to the notification (any issue I find on my rounding ect). Any other thoughts on this?


Anastasia

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Attachment. clia-laboratory-directors-responsibilities-041316.pdfCMS has a document called Laboratory Director Responsibilities. You could take information from that to present to them, or give them the document to review.

Hi,


Don't forget to get delegation letters for POCC that will be reviewing QC, proficiency testing, competencies, procedures, method validations, etc. Otherwise, the lab director will need to sign everything.  If you have technical directors that review, make sure they also have delegation letters.


Thanks,


Reine

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Anastasia Augustine
over 5 years ago
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