Principle: | Procedure: | References:
Biological Recall, Market Withdrawal or Lookback
Blood products may be quarantined, returned or destroyed upon notification by the blood supplier for a variety of reasons. A biological recall indicates the product was incorrectly collected or processed. A market withdrawal is associated with a product that has been delivered to the consignee but now additional information on the donor makes the product unsuitable for transfusion. A lookback is initiated when the supplier finds a donor to have a transfusion transmissible disease and contacts the consignees to determine the disposition of past donations from this donor, possibly going back years. Once the process is initiated the response is similar in all cases.
1. Phone call / FAX from Blood Supplier:
A. Using the “UCL Lookback Documentation” form, document the:
a. Name of caller
b. Time and date of call
c. Reason/problem for the call (if applicable)
B. Open the SafeTrace Inventory Module.
C. Click File (Main Menu), Open, Component
The Open Component Window opens
D. Type the component number in the “Unit No:” field and click “Query” to open the General Component window
Warning: If more than one component was delivered to a UCL site with this component number, all components must be accessed and tracked.
E. The “Status” of the unit can be seen. Print this screen by using the “Print Screen” key on the keyboard.
F. Status: Transfused:
Note: Transfused components do not have to be immediately acted upon unless the recall is for bacterial contamination of a platelet pheresis. Bacterial contamination of a transfused platelet pheresis must be followed through and a pathologist contacted immediately. If the transfused product was not implicated in a bacterial contamination recall the partially completed paperwork may be left for the blood bank supervisor or designee or if time permits continue with the next steps.
a. If the unit has been transfused, go to Components (Menu Bar), Override
b. Type in the comment “Recalled” and click “OK”.
c. A “Factors Exist” warning will appear, click [Yes], and then click [OK].
d. The factor posts to the component screen under “Prohibiting Factor” allowing future lookbacks to identify this unit as having been recalled after it was transfused. Click “OK”.
e. Click the “Orders” option on the component menu bar. The patient that received the component is shown
Print this screen by using the “Print Screen” key on the keyboard.
f. Complete the Lookback form, attaching both print screens, and place in the designated file for supervisory/pathology review, unless the recall was for bacterial contamination of a platelet pheresis. In this case call a pathologist immediately and refer to the “Suggested Hospital Response to MVRBC Platelet Cultures” algorithm at the end of this procedure.
G. Status “Available”:
a. Locate the component and place a Quarantine label (found in supplier area at each site) on the component.
b. Follow the blood supplier’s directions to either return the component to them (refer to “Shipping, Components; Inventory Module: SafeTrace” procedure) or discard the component on site (refer to “Discarding Components; SafeTrace” procedure).
c. Complete the UCL Lookback form, attach a copy of the shipment document or discard screen to the completed form.
H. Complete the blood supplier’s FAX form (if one was received) and FAX per directions on the form. Attach the completed FAX form to the UCL Lookback form.
Note: A response to the Blood Supplier must be made within 30 days of receipt of the lookback notification.
I. All paperwork is filed in the designated area for further review by the blood bank supervisor or designee. A pathologist makes the final determination if patient notification is warranted. The hospitals’ Infection Control departments handle any patient notification and have processes in place to do this.
J. Completed lookbacks are filed in the Lookback/Recall file for at least 10 years.
2. Letter of Recall, Withdrawal, or Lookback received from blood supplier:
A. Check the records for documentation of Phone/FAX notification.
a. If none, follow the steps in Phone/FAX procedure above.
b. If Phone/FAX documentation is completed, attach these to the letter and place in the designated area for further review by the blood bank supervisor or designee.
B. Letters from the blood supplier and all documentation are brought to the attention of a pathologist for further instruction. A pathologist makes the final determination if patient notification is warranted. The hospitals’ Infection Control departments handle any patient notification and have processes in place to do this.
C. Completed lookbacks are filed in the Lookback/Recall file for at least 10 years.
3. Notification from physician/office:
A. Patient received a blood component and patient’s physician is reporting a problem or a concern.
B. Begin documentation on the bottom half of the UCL Lookback form.
C. Refer to the “Transfusion Reaction” procedure section IX. Results Derivation for directions on how to proceed.
1. AABB Technical Manual. Latest version.
2. AABB Standards for Blood Banks and Transfusion Services. Latest version.
3. SafeTrace Tx® Inventory Training Manual. 04/01/2001
4. Mississippi Valley Regional Blood Center handbook, communications
i. April 2005 S. Rodriguez
May 2010 S. Hosch (Revised: II.1.F.b., d., H.note)
August 2011 L. Cooksley (Revised: 2.G.a., 3.C.)