Principle:

All therapeutic apheresis procedures are potentially life-threatening and must only occur by an order from a transfusion medicine physician with experience/competence in such procedures.

Definitions:

• Referring Physician is the clinical physician requesting a therapeutic apheresis procedure.
• Transfusion Medicine Physician is a physician in the Transfusion Medicine Section with medical privileges for therapeutic apheresis procedures.  This includes the Head, Transfusion Medicine, consultants in Transfusion Medicine, and designated specialist physicians in Transfusion Medicine.  The final decision to accept/reject the patient is made by the transfusion medicine physician.
• Covering Physician is the clinical physician designated by the referring physician to be physically present and covering the patient in case of any adverse reactions during a therapeutic apheresis procedure.
• Apheresis Nurses are nurses in Transfusion Medicine who are designated by this section for performing therapeutic apheresis procedures.
• Medical Privileges are determined by the Department of Pathology and Laboratory Medicine in conjunction with the HMC medical privileging by the Medical Director.

Policy:

1. The referral physician will discuss the request for a therapeutic apheresis with the designated transfusion medicine physician.  The referral physician must certify that the patient can tolerate the procedure based on his medical condition.
2. The transfusion medicine physician will review the patient’s clinical and laboratory data, with special note of the history of allergies, medications, previous transfusion reactions, and current vital signs.
3. Vascular access will be initially assessed by the apheresis nurse.  Any questionable situations will be reviewed by the transfusion medicine physician.
4. The following laboratory values (less than 24 hours old) must be available before the procedure may begin:
   1. CBC including platelet count
   2. PT and APTT
   3. Fibrinogen
   4. Serum calcium
   5. Serum protein and albumin
   6. LDH for TTP cases
5. A valid type and screen must have been done within the previous three days of the procedure.
6. Upon review of # 2 through 5, the transfusion medicine physician will determine if the procedure is indicated and will communicate this to the referral physician, who will sign written order in the patient chart.  Appropriate replacement fluids will also be mutually agreed upon in advance of the procedure and ordered by the transfusion medicine physician.  The order specification must include:
   1. Name of procedure and specification (e.g. therapeutic plasma exchange, isovolemic)
   2. Replacement fluid type and volume (e.g. 3 liters 5% albumin, 2 liters, FFP, cryoprecipitate, normal saline)
   3. Blood component orders if indicated (e.g. RBC exchange) and timing (before, during, and/or after the procedure)
   4. Calcium replacement (e.g. 2 grams calcium gluconate IV in 100 ml normal saline to run during the procedure)
   5. Any special laboratory testing post-procedure
7. The apheresis nurse will follow the orders of the necessary prescribed replacement fluids (FFP, albumin, PPF) in the quantities necessary for the exchange.
8. The referring physician will obtain the signed, informed consent from the patient.
9. If vascular access is unsatisfactory, the referring physician will obtain the proper access (central line, AV shunt, etc.).
10. The referring physician will arrange for a physician member of his team to be present at the actual therapeutic procedure.  This physician designate will be responsible to treat any complications arising from the procedure.
11. Vital signs and weight will be obtained before starting the procedure.
12. When approved by the Blood Bank Director or designate with proper venous access and informed consent, the apheresis may start the procedure in the presence of the patient’s covering physician.  The procedure will be performed in a designated hospital area.
13. The procedure must be documented on the appropriate therapeutic apheresis order and procedure worksheets.

References:

1. Standards for Blood Banks and Transfusion Services Current Edition, AABB, Bethesda, MD, USA
2. CAP Standard TRM.42245 regarding therapeutic apheresis procedures