I work a the hospital Blood Donor Rm. and Apheresis dept. We used to do Therapeutic phlebotomy on inpts during normal working hours if we had a free nurse. Now we have an SOP for the floor nurse to perform the procedure. We will assist them if needed.
Do facilities need to meet any special regulatory requirements through AABB or FDA in order to perform TP? We are trying to bring TP to our hospital-based outpatient oncology clinic, but my Blood Bank says they need to modify their license first, based on FDA requirements. Can someone help me understand this?
Keith W. Gilchrist, MSN, RN, PHN, OCN, CRNI, VA-BC
Oncology Nurse Navigator, David Grant Medical Center
Travis AFB, CA
They are probably referring to regulations/requirements for handling blood collection and disposal. I am not familiar with what your lab may be required to do. To handle blood returned to the lab following TP, I don't think this is the same requirements for handling blood taken from donors for processing to recipients. The lab may not be clear about what you want to do or there could be some aspects of requirements from AABB that I am not familiar with. I don't think this would be coming from FDA but maybe.
Therapeutic phlebotomy cannot be used to transfuse others, as a rule. They are being phlebotomized for a medical reason and their blood may not be suitable for others. This blood must be discarded as medical waste. The FDA has allowed waivers for some persons with Hereditary Hemachromatosis. We can use their blood for transfusion as long as our criteria is met. To perform a therapeutic phlebotomy requires an MD's order with volume to remove (usually 450 -500mL, same as a donor), over what length of time (5-20 min), replacement fluid (if needed), and reason for phlebotomy (i.e., polycythemia, hemachromatosis) Our Blood Bank Director does not want this done more freq than 2-3 days. Requires CBC prior to each TP. It is performed in our outpt cancer center and in MD's offices. Hope this helps.
Infusion nurses.
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
I work a the hospital Blood Donor Rm. and Apheresis dept. We used to do Therapeutic phlebotomy on inpts during normal working hours if we had a free nurse. Now we have an SOP for the floor nurse to perform the procedure. We will assist them if needed.
Do facilities need to meet any special regulatory requirements through AABB or FDA in order to perform TP? We are trying to bring TP to our hospital-based outpatient oncology clinic, but my Blood Bank says they need to modify their license first, based on FDA requirements. Can someone help me understand this?
Keith W. Gilchrist, MSN, RN, PHN, OCN, CRNI, VA-BC
Oncology Nurse Navigator, David Grant Medical Center
Travis AFB, CA
They are probably referring to regulations/requirements for handling blood collection and disposal. I am not familiar with what your lab may be required to do. To handle blood returned to the lab following TP, I don't think this is the same requirements for handling blood taken from donors for processing to recipients. The lab may not be clear about what you want to do or there could be some aspects of requirements from AABB that I am not familiar with. I don't think this would be coming from FDA but maybe.
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
Therapeutic phlebotomy cannot be used to transfuse others, as a rule. They are being phlebotomized for a medical reason and their blood may not be suitable for others. This blood must be discarded as medical waste. The FDA has allowed waivers for some persons with Hereditary Hemachromatosis. We can use their blood for transfusion as long as our criteria is met. To perform a therapeutic phlebotomy requires an MD's order with volume to remove (usually 450 -500mL, same as a donor), over what length of time (5-20 min), replacement fluid (if needed), and reason for phlebotomy (i.e., polycythemia, hemachromatosis) Our Blood Bank Director does not want this done more freq than 2-3 days. Requires CBC prior to each TP. It is performed in our outpt cancer center and in MD's offices. Hope this helps.