Looking for a hospital that has a separate hematology analyzer (Hematology/Oncology office or suite) from the main lab.
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Hello everyone,
Looking for some insight.
We are a small community hospital <100 beds that has an oncology/hematology suite with its own hematology analyzer. Currently it has its own director and CLIA number - CMS/CLIA inspected. Same address as the main lab.
We are looking at rolling this into our CAP and CLIA number. The transition is a grey area for me from a regulatory point of view. If anyone has dealt with this type of situation or has a similar setup, I would appreciate any insight.
Thank you and Happy New Year
Amanda
Looking for some insight.
We are a small community hospital <100 beds that has an oncology/hematology suite with its own hematology analyzer. Currently it has its own director and CLIA number - CMS/CLIA inspected. Same address as the main lab.
We are looking at rolling this into our CAP and CLIA number. The transition is a grey area for me from a regulatory point of view. If anyone has dealt with this type of situation or has a similar setup, I would appreciate any insight.
Thank you and Happy New Year
Amanda
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Is it moderate/high complexity or waived testing?
For CLIA - you would need to let them know that you have a secondary testing location within the hospital and the testing being performed. Since it is on the same property and same address, you should not need to do anything further with them.
For CAP, you would need to add the testing to your point of care testing activity menu. You also need to add the analyzer to your equipment list, and add the operators to your non-laboratory testing staff list - I keep them on my point of care list. You likely already perform the CAP Proficiency on your in-lab hemo analyzers so you won't need to enroll in any PT but will need alternative proficiency. If non-waived however, you will need to get them into your correlations rotation.